FDA Adverse Event
Injury
Summary report: N
CONTAK RENEWAL
MDR report key: 2920870
·
Received January 17, 2013
Report
- Report Number
- 2124215-2013-01130
- Event Type
- Injury
- Date Received
- January 17, 2013
- Date of Event
- November 2, 2012
- Report Date
- November 13, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL NOT BE RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN EXPECTED DUE TO A RANDOM COMPONENT FAILURE. THE DEVICE WAS EXPLANTED SUBSEQUENTLY EXPLANTED FOR NORMAL BATTERY DEPLETION. EFFORTS TO OBTAIN ADDITIONAL DETAILS REGARDING THE CLINICAL OBSERVATIONS WERE UNSUCCESSFUL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25902 | CONTAK RENEWAL | IMPLANTABLE CHF GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | H217 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization| L | 4512| 4064| H217| 0157| H175| H135| 4046 |