CONCERTO II CRT-D
Report
- Report Number
- 2647346-2010-00925
- Event Type
- Death
- Date Received
- December 14, 2010
- Date of Event
- November 10, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S125
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE LEADS ARE IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4):THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), INNER INSULATION TORN, THE OUTER INSULATION WAS BREACHED AND COSMETIC CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE. EVALUATION SUMMARY: (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, OUTER TUBING OVERLAY WITH COSMETIC ENVIRONMENTAL STRESS CRACK, OUTER TUBING OVERLAY WAS BREACH CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE. THE OUTER TUBING HAD ENVIRONMENTAL STRESS CRACKS NON-ELECTRICAL AND OVERLAY BREACH CUT. ALSO, THE OUTER INSULATION HAD A COSMETIC CUT, AND THERE WAS A DEFORMATION/FRACTURE IN FIVE CM PROXIMAL SECTION OF THE INNER COIL WITH EXTENSION PROBLEMS.
ASKU
IT WAS REPORTED THAT THE PATIENT COLLAPSED AT HOME AND WAS UNRESPONSIVE. EMERGENCY MEDICAL SERVICES WERE CALLED AND CPR WAS INITIATED. THE PATIENT DIED IN THE ER. THE DEVICE WAS INTERROGATED POST MORTEM AND NO ARRHYTHMIAS WERE FOUND AT TIME OF COLLAPSE AND LEAD AND DEVICE FUNCTION APPEARED APPROPRIATE. WAS NOTED THAT ABOUT 8-10 MINUTES PRIOR TO ER ARRIVAL, "THERE WAS AN ARRHYTHMIA IN THE 140 BPM RANGE." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. LEAD IMPLANT HAD BEEN APPROXIMATELY 5 MONTHS PRIOR TO DEATH.
IT WAS REPORTED THAT THE PATIENT COLLAPSED AT HOME AND WAS UNRESPONSIVE. EMERGENCY MEDICAL SERVICES WERE CALLED AND CPR WAS INITIATED. THE PATIENT DIED IN THE ER. THE DEVICE WAS INTERROGATED POST MORTEM AND NO ARRHYTHMIAS WERE FOUND AT TIME OF COLLAPSE AND LEAD AND DEVICE FUNCTION APPEARED APPROPRIATE. WAS NOTED THAT ABOUT 8-10 MINUTES PRIOR TO ER ARRIVAL, "THERE WAS AN ARRHYTHMIA IN THE 140 BPM RANGE." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. LEAD IMPLANT HAD BEEN APPROXIMATELY 5 MONTHS PRIOR TO DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONCERTO II CRT-D | ASKU | NIK | MEDTRONIC MED REL, INC. | D274TRK | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Death| H| L| R | LEAD/ENPATH IMPLANTABLE PACING LEAD| LEAD/ENPATH IMPLANTABLE PACING LEAD| COMPETITOR'S IMPLANTABLE PACING LEAD| COMPETITOR'S IMPLANTABLE PACING LEAD| COMPETITOR'S IMPLANTABLE PACING LEAD |