FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1945802
·
Received January 4, 2011
Report
- Report Number
- 2124215-2010-20284
- Event Type
- Injury
- Date Received
- January 4, 2011
- Date of Event
- September 29, 2010
- Report Date
- January 27, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
A TECHNICAL SERVICES CONSULTANT RECOMMENDED CHANGING THE SENSITIVITY TO RESOLVE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. AS OF TODAY, THE LEAD REMAINS IN SERVICE.
Additional Manufacturer Narrative · 1
IT WAS LATER REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO A PATIENT CONDITION AND THE LEAD WAS SURGICALLY ABANDONED.
Description of Event or Problem · 1
--
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD OVERSENSED NOISE ON THE RESULTING IN PACING INHIBITION AND ASYSTOLE FOR MORE THAN TWO SECONDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention | 4087| 0158| N119| H177 |