FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2052584
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-03645
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 24, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
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 DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE, PERIODS OF ASYSTOLE GREATER THAN 2 SECONDS, WERE EXHIBITED WITH THIS RIGHT VENTRICULAR LEAD, REPORTEDLY DUE TO OVERSENSING. ADDITIONALLY, INAPPROPRIATE THERAPY WAS NOTED; HOWEVER, ALL MEASUREMENTS WERE ACCEPTABLE. DURING THE PROCEDURE, THE PHYSICIAN CAPPED THE IS-1 PORTION AND IMPLANTED ANOTHER BOSTON SCIENTIFIC LEAD, RESOLVING THE ISSUE. NO ALLEGATIONS AGAINST THE EXPLANTED DEVICE AND NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |