FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3212489
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09434
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- May 24, 2013
- Report Date
- May 25, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- 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 IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. ADDITIONALLY, THE LEAD EXHIBITED NOISE. THE NOISE WAS OVERSENSED RESULTING IN INAPPROPRIATE SHOCKS. THE LEAD WAS OBSERVED TO HAVE FRACTURED. AN INVASIVE PROCEDURE WAS PERFORMED. THE RATE/SENSE PORTION OF THE LEAD WAS SURGICALLY ABANDONED AND A NEW RIGHT VENTRICULAR (RV) RATE/SENSE LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312000 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Hospitalization| L| R | 0181| 4517| H229 |