CONSULTA CRT-D
Report
- Report Number
- 6000094-2012-02456
- Event Type
- Injury
- Date Received
- October 31, 2012
- Report Date
- November 27, 2012
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- NIK
- Removal / Correction Number
- Z-0111-2011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY: (B)(4) - PERFORMANCE DATA FROM THE DEVICE WAS ANALYZED AND REVEALED THAT THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT=2.974 TO 2.652 VOLTS BETWEEN (B)(4) 2012 AND IS BEFORE DEVICE RECOMMENDED REPLACEMENT, WHICH IS <= 2.651 VOLTS.
PRODUCT EVALUATION SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND ANALYSIS REVEALED THAT THE DEVICE MET 66% OF THE EXPECTED LONGEVITY. (B)(4).
IT WAS REPORTED THAT THE DEVICE HAD AN UNEXPECTED LONGEVITY AS IT REACHED ITS RECOMMENDED REPLACEMENT TIME (RRT) AFTER 2.5 YEARS OF SERVICE LIFE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE DEVICE HAD AN UNEXPECTED LONGEVITY AS IT REACHED ITS RECOMMENDED REPLACEMENT TIME (RRT) AFTER 2.5 YEARS OF SERVICE LIFE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSULTA CRT-D | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC S.A. | D234TRK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization| R |