FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3210336
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-09433
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 13, 2013
- Report Date
- April 13, 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 (RV) LEAD HAD FRACTURED WHICH CAUSED THE DELIVERY OF INAPPROPRIATE THERAPY TO THE PATIENT. A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT OF GREATER THAN 2000 OHMS WAS ALSO NOTED AS WELL AS HIGH PACING THRESHOLDS. SURGICAL INTERVENTION WAS PERFORMED TO ABANDON THE LEAD IN THE PATIENT AND REPLACE IT WITH A NEW RV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310775 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| L| R | 0158| E030| 4136 |