FDA Adverse Event
Malfunction
Summary report: N
PROMOTE PLUS CRT-D, DF-4 CONNECTOR
MDR report key: 2242618
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06572
- Event Type
- Malfunction
- Date Received
- September 10, 2011
- Date of Event
- July 1, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT INTERMITTENT HIGH LEAD IMPEDANCE MEASUREMENTS WERE FOUND VIA (B)(4). PATIENT WAS BROUGH IN CLINIC, AND ALL IMPEDANCE MEASUREMENTS WERE IN-RANGE. PATIENT TO BE MONITORED.
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 | 65 YR |