FDA Adverse Event
Injury
Summary report: N
PROMOTE PLUS CRT-D, DF-4 CONNECTOR
MDR report key: 1831102
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03606
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- July 22, 2010
- 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
- SC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
A FULL EVALUATION OF THE DEVICE FUNCTIONALITY WAS PERFORMED. THE DEVICE DEMONSTRATED NORMAL FUNCTION DURING BENCH AND ATE TESTING. A TEST SHOCK WAS INITIATED AND SUCCESSFULLY COMPLETED. NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING INTERROGATION OF THE DEVICE, NO RV-WAVE CAPTURE WAS NOTED. THE DEVICE WAS REPROGRAMMED. DFT TESTING WAS PERFORMED ON (B)(6) 2010, AND TESTING WAS SUCCESSFUL. THE PHYSICIAN DECIDED TO HOLD OFF ON SURGERY. THE PATIENT IS BEING PACED LV ONLY SINCE RV IS STIL NOT CAPTURING.
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 | 73 YR | Required Intervention | 7121Q (B)(4) |