FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-D
MDR report key: 2864818
·
Received December 10, 2012
Report
- Report Number
- 3004209178-2012-11428
- Event Type
- Injury
- Date Received
- December 10, 2012
- Report Date
- October 1, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NIK
- PMA / PMN Number
- P010031/S084
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4). EVALUATION SUMMARY: (B)(4): UPON ANALYSIS, NORMAL BATTERY DEPLETION WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE LASTED LESS THAN 3 YEARS AND THE ELECTROPHYSIOLOGIST WAS CONCERNED WITH THE LONGEVITY. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSULTA CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D224TRK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | Hospitalization| R |