FDA Adverse Event
Injury
Summary report: N
PROMOTE RF CRT-D
MDR report key: 2242832
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06203
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- July 26, 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
- VA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DURING ANALYSIS NO COMMUNICATION COULD BE ESTABLISHED BETWEEN THE DEVICE AND THE PROGRAMMER. NO HIGH CURRENT WAS DETECTED, AND POWER CONSUMPTION OF THE DEVICE WAS MEASURED AND FOUND TO BE NORMAL. THE CAUSE OF THE BATTERY DEPLETION WAS UNDETERMINED.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PHYSICIAN WAS UNABLE TO INTERROGATE THE DEVICE. DEVICE WAS EXPLANTED AND REPLACED.
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 | 71 YR | Required Intervention |