FDA Adverse Event
Injury
Summary report: N
ENDOTAK DSP
MDR report key: 3053629
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-05282
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- February 21, 2013
- Report Date
- March 21, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD, EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE PHYSICIAN ELECTED TO SURGICALLY INTERVENE AND EXPLANT THIS PRODUCT. DURING THE PROCEDURE THE RV LEAD WAS UNABLE TO BE FULLY EXTRACTED AND AS A RESULT WAS ONLY PARTIALLY EXPLANTED. THE EXPLANTED SECTION WILL NOT BE RETURNED FOR LABORATORY ANALYSIS. A COMPETITOR RV LEAD WAS SUCCESSFULLY IMPLANTED AND THE REMAINDER OF THE CHRONIC LEAD, SURGICALLY ABANDONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154447 | ENDOTAK DSP | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| L| R | MISMATCH| N119| 1783| 1860| 0125| 4554 |