FDA Adverse Event
Injury
Summary report: N
CONTAK RENEWAL
MDR report key: 3213159
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-08854
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- June 3, 2013
- Report Date
- October 8, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED AND ANALYZED BY THE POST MARKET QUALITY ASSURANCE LABORATORY. DETAILED ANALYSIS WAS PERFORMED TO VERIFY THE BATTERY DEPLETION, PACING, SENSING, SHOCKING AND RECORDING FUNCTIONS. THIS DEVICE SHOWED NORMAL BATTERY DEPLETION AND PASSED ALL TESTING.
Additional Manufacturer Narrative · 1
TO DATE, THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THE DEVICE WILL UNDERGO DETAILED ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.
Description of Event or Problem · 1
--
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS REMOVED AND REPLACED DUE TO SUSPECTED PREMATURE BATTERY DEPLETION (PBD). THE DEVICE WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312544 | CONTAK RENEWAL | IMPLANTABLE CHF GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | H195 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| L| R | 4517| 0165| 4480| H195 |