FDA Adverse Event
Malfunction
Summary report: N
CONSULTA CRT-D
MDR report key: 2790741
·
Received October 15, 2012
Report
- Report Number
- 6000144-2012-05712
- Event Type
- Malfunction
- Date Received
- October 15, 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
- AZ, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE REACHED EARLY BATTERY DEPLETION DUE TO ELEVATED THRESHOLD WITH THE ATRIAL LEAD. THEREFORE THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. THE ATRIAL LEAD REMAINS IN USE. IT WAS NOTED THAT THE PATIENT IS PART OF THE (B)(4). 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 | 64 YR | Hospitalization| R | 7000 COMPETITOR IMPLANTABLE TACHY LEAD| 4196 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB |