FDA Adverse Event
Malfunction
Summary report: N
CONSULTA
MDR report key: 1990296
·
Received February 15, 2011
Report
- Report Number
- 6000144-2011-00691
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S084
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, 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 STORED EGM SHOWS INVALID DATA. THE PATIENT HAD CT SCANS AND RADIATION THERAPIES SINCE THE EPISODES WERE STORED. THE DEVICE REMAINS IN USE. 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 | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | D224TRK | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other | (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD |