FDA Adverse Event
Injury
Summary report: N
PROMOTE ACCEL CRT-D
MDR report key: 2083912
·
Received May 11, 2011
Report
- Report Number
- 2017865-2011-03760
- Event Type
- Injury
- Date Received
- May 11, 2011
- Date of Event
- March 3, 2011
- 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED ANALYSIS OF THE DEVICE FOUND A SEVERED CAN WIRE CONNECTION AS THE CAUSE FOR THE REPORTED HIGH IMPEDANCE MEASUREMENTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN WAS RECEIVING OUT-OF-RANGE IMPEDANCE MEASUREMENTS. THE LEAD WAS REPLACED. THE VALUES REMAINED THE SAME. THE ICD WAS THEN REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROMOTE ACCEL CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3215-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | (B)(4) |