FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-D
MDR report key: 2810963
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06292
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S084
- Removal / Correction Number
- Z-0111-2011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, 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. EVALUATION SUMMARY (B)(4): THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED. THE DEVICE MET 80% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE POTENTIALLY REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) PREMATURELY DUE TO BATTERY DEPLETION IN LESS THAN FOUR YEARS. 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 MED REL, INC. | D224TRK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| L| R | 4195 IMPLANTABLE PACING LEAD| 5594 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |