FDA Adverse Event
Injury
Summary report: N
PROMOTE PLUS CRT-D, DF-4 CONNECTOR
MDR report key: 1831101
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03605
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- September 8, 2009
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED LATE, DUE TO DELAY IN RECEIVING PAPERWORK.
Additional Manufacturer Narrative · 1
ANALYSIS WAS NORMAL. THE DEVICE WAS TESTED ON THE BENCH AND THE AUTOMATED SYSTEM. NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING INITIAL IMPLANT PROCEDURE DFT TESTING WAS UNSUCCESSFUL. THE PATIENT REQUIRED EXTERNAL DEFIBRILLATION AT MAXIMUM OUTPUTS. THE PHYSICIAN OPTED TO TRY AGAIN A FEW DAYS LATER DUE TO PATIENT'S HEALTH. ATTEMPTED DFT TESTING AGAIN AND WAS UNSUCCESSFUL. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROMOTE PLUS CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | 7120Q/58 (B)(4) |