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IMPLANTABLE PACING LEAD|MEDTRONIC PUERTO RICO, INC.|SUREFIX|IT WAS REPORTED IMPEDANCE CHECKS WERE CONSISTENTLY|1643318

admin — Sat, 01 Oct 2011 16:23:56 +0000

IT WAS REPORTED IMPEDANCE CHECKS WERE CONSISTENTLY HIGH AND DETERMINED TO BE A LEAD ISSUE. THE RV (RIGHT VENTRICULAR) AND ATRIAL LEADS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Date Reported:| Report Number:2649622-2010-01283| Date received:Mar 29, 2010
Type:Initial submission
Source:Manufacturer report

IMPLANTABLE PACING LEAD|MEDTRONIC PUERTO RICO, INC.|SUREFIX|THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA|1643318

admin — Sat, 01 Oct 2011 16:23:56 +0000

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B) (4) DEFIB CONDUCTOR FRACTURED; FULL LEAD RETURNED IN SEGMENTS. (B) (4) OUTER INSULATION BREACHED (CLAVICLE-RIB CRUSH); DISTAL SEGMENT RETURNED.
Date Reported:| Report Number:2649622-2010-01283| Date received:Mar 29, 2010
Type:Initial submission
Source:Manufacturer report

IMPLANTABLE TACHY LEAD|MEDTRONIC PUERTO RICO, INC.|SPRINT QUATTRO SECURE|THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA|1643317

admin — Sat, 01 Oct 2011 16:23:56 +0000

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B) (4) DEFIB CONDUCTOR FRACTURED; FULL LEAD RETURNED IN SEGMENTS. (B) (4) OUTER INSULATION BREACHED (CLAVICLE-RIB CRUSH); DISTAL SEGMENT RETURNED.
Date Reported:| Report Number:2649622-2010-01282| Date received:Mar 29, 2010
Type:Initial submission
Source:Manufacturer report

IMPLANTABLE TACHY LEAD|MEDTRONIC PUERTO RICO, INC.|SPRINT QUATTRO SECURE|IT WAS REPORTED IMPEDANCE CHECKS WERE CONSISTENTLY|1643317

admin — Sat, 01 Oct 2011 16:23:56 +0000

IT WAS REPORTED IMPEDANCE CHECKS WERE CONSISTENTLY HIGH AND DETERMINED TO BE A LEAD ISSUE. THE RV (RIGHT VENTRICULAR) AND ATRIAL LEADS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Date Reported:| Report Number:2649622-2010-01282| Date received:Mar 29, 2010
Type:Initial submission
Source:Manufacturer report

IMPLANTABLE TACHY LEAD|MEDTRONIC PUERTO RICO, INC.|SPRINT QUATTRO SECURE|IT WAS REPORTED THAT THERE WAS OVERSENSING|1643316

admin — Sat, 01 Oct 2011 16:23:56 +0000

IT WAS REPORTED THAT THERE WAS OVERSENSING AND LOW IMPEDANCE LESS THAN 200 OHMS. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Date Reported:| Report Number:2649622-2010-01281| Date received:Mar 29, 2010
Type:Initial submission
Source:Manufacturer report

IMPLANTABLE TACHY LEAD|MEDTRONIC PUERTO RICO, INC.|SPRINT QUATTRO SECURE|THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA|1643316

admin — Sat, 01 Oct 2011 16:23:56 +0000

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Date Reported:| Report Number:2649622-2010-01281| Date received:Mar 29, 2010
Type:Initial submission
Source:Manufacturer report

IMPLANTABLE PACEMAKER/CARDIO/DEFIB|MEDTRONIC MED REL, INC.|VIRTUOSO DR|THE DEVICE WAS REPLACED DUE TO ERI|1643315

admin — Sat, 01 Oct 2011 16:23:56 +0000

THE DEVICE WAS REPLACED DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Date Reported:| Report Number:6000144-2010-01178| Date received:Mar 29, 2010
Type:Initial submission
Source:Manufacturer report

IMPLANTABLE PACEMAKER/CARDIO/DEFIB|MEDTRONIC MED REL, INC.|VIRTUOSO DR|THIS REPORT IS BASED SOLELY ON DEVICE|1643315

admin — Sat, 01 Oct 2011 16:23:56 +0000

THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B) (4) A HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DEVICE ANALYSIS. ELECTRICAL ANALYSIS FOUND THE CAUSE OF THE HIGH CURRENT DRAIN TO BE CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.
Date Reported:| Report Number:6000144-2010-01178| Date received:Mar 29, 2010
Type:Initial submission
Source:Manufacturer report

IMPLANTABLE PACEMAKER/CARDIO/DEFIB|MEDTRONIC MED REL, INC.|CONCERTO CRT-D DR|THIS REPORT IS BASED SOLELY ON DEVICE|1643314

admin — Sat, 01 Oct 2011 16:23:56 +0000

THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B) (4) A HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DEVICE ANALYSIS. ELECTRICAL ANALYSIS FOUND THE CAUSE OF THE HIGH CURRENT DRAIN TO BE CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.
Date Reported:| Report Number:6000144-2010-01177| Date received:Mar 29, 2010
Type:Initial submission
Source:Manufacturer report

IMPLANTABLE PACEMAKER/CARDIO/DEFIB|MEDTRONIC MED REL, INC.|CONCERTO CRT-D DR|IT WAS REPORTED THE DEVICE WAS ELECTIVELY|1643314

admin — Sat, 01 Oct 2011 16:23:56 +0000

IT WAS REPORTED THE DEVICE WAS ELECTIVELY REPLACED AFTER LONGEVITY OF LESS THAN FOUR YEARS. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER’S ANALYSIS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Date Reported:| Report Number:6000144-2010-01177| Date received:Mar 29, 2010
Type:Initial submission
Source:Manufacturer report