FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK DSP
MDR report key: 1945722
·
Received January 4, 2011
Report
- Report Number
- 2124215-2010-20581
- Event Type
- Malfunction
- Date Received
- January 4, 2011
- Date of Event
- June 9, 2009
- Report Date
- October 12, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IMPLANTED. AT THIS TIME, INVESTIGATION IS COMPLETE. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN ASSOCIATION WITH THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD OVERSENSED ATRIAL FIBRILLATION AND DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY, LEADING TO EXHAUSTION OF THERAPY. THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM AS A RESULT OF THE INAPPROPRIATE THERAPY DELIVERY, BUT WAS ASYMPTOMATIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK DSP | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | 4512| H175| 0125| 1823| H215| 4469 |