FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK DSP
MDR report key: 2161269
·
Received July 13, 2011
Report
- Report Number
- 2124215-2011-06804
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Date of Event
- February 28, 2011
- Report Date
- April 14, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE RIGHT VENTRICULAR LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED HIGH SHOCK IMPEDANCES. THE SHOCK VECTORS INCLUDING THE SVC COIL APPEARED TO BE OUT OF RANGE INDICATING AN ISSUE WITH THE SVC COIL. THE DECISION WAS MADE TO REPROGRAM THE RV SHOCK VECTOR TO THE CAN AND NOT REPLACE THE LEAD AT THIS TIME DUE TO THE PATIENT'S CONDITION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
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 | 62 YR | Other | 4245| 0125| 1821| 1871| T167 |