FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1954246
·
Received January 10, 2011
Report
- Report Number
- 2124215-2011-00062
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- December 15, 2010
- Report Date
- December 15, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVISION PROCEDURE WAS PERFORMED. A FRACTURE WAS NOTED ON X-RAY. THE LEAD COULD NOT BE EXPLANTED AS THE GUIDE WIRE WOULD NOT PASS THROUGH THE FRACTURE AREA. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. 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 A PACING IMPEDANCE MEASUREMENT GREATER THAN 2,500 OHMS. THE PACING THRESHOLD HAD ALSO INCREASED. A FRACTURE WAS SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 4542| H190| 4096| 0161| P107 |