FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-D
MDR report key: 2051254
·
Received April 12, 2011
Report
- Report Number
- 6000144-2011-01513
- Event Type
- Injury
- Date Received
- April 12, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S084
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
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 BY THE PATIENT THAT THE "LEAD WAS DRAINING THE BATTERIES AND HE HAS NEEDED A REPLACEMENT EVERY TWO YEARS". IT WAS ALSO REPORTED THAT THE LEAD HAD HIGH THRESHOLD. THE DEVICE WAS EXPLANTED AND REPLACED AND THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REEPORTED 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 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization| R | 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |