FDA Adverse Event
Malfunction
Summary report: N
CONSULTA
MDR report key: 1925315
·
Received December 14, 2010
Report
- Report Number
- 6000144-2010-06288
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- 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
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 SHOWED DOUBLE COUNTING OF R-WAVES ALONG WITH ONE OVERSENSED EVENT. IT WAS ALSO REPORTED IT OCCURRED AT IMPLANT AND RESOLVED OVER TIME AND MAY HAVE BEEN AN OPEN GROMMET THAT HAS SINCE SEALED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE 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 | 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |