FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3211050
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-08146
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- May 2, 2013
- Report Date
- May 2, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SHOCKING PORTION OF THIS LEAD REMAINS ACTIVELY IMPLANTED. 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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT, NOISE WITH OVERSENSING LEADING TO INAPPROPRIATE THERAPY. THE PACING PORTION OF THIS LEAD WAS SURGICALLY ABANDONED AND A NEW RV LEAD IMPLANTED WITHOUT ISSUE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311430 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization| L| R | 0148| 4513| 4087| H175| H135| N118 |