FDA Adverse Event
Injury
Summary report: N
PROMOTE RF CRT-D
MDR report key: 2242992
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06205
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- June 14, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED DUE TO A SUSPECTED MALFUNCTION. AN ALERT OF POSSIBLE HIGH VOLTAGE LEAD ISSUE WAS RECEIVED UPON INTERROGATION. AFTER CLEARING THE ALERT, THE DEVICE WAS TESTED ON THE BENCH AND ON OUR AUTOMATED TESTING EQUIPMENT AND FOUND TO BE NORMAL. ASSOCIATED LEAD WAS CAPPED AND NOT RETURNED FOR ANALYSIS.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE EXPLANTED DUE TO A SUSPECTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROMOTE RF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 3207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention | (B)(4) |