FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-D
MDR report key: 2810543
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-05902
- 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
- WI, 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): UPON ANALYSIS, NORMAL BATTERY DEPLETION WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS POSSIBLE EARLY BATTERY DEPLETION AND THE DEVICE WAS AT ERI (ELECTIVE REPLACEMENT INDICATOR). 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 | 78 YR | Hospitalization| R | 4194 IMPLANTABLE PACING LEAD| 6935 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD |