FDA Adverse Event
Malfunction
Summary report: N
KAPPA 900 DR
MDR report key: 1923096
·
Received December 13, 2010
Report
- Report Number
- 2647346-2010-00850
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Date of Event
- September 16, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/014
- 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 PATIENT'S DEVICE HAD EXHIBITED ELECTIVE REPLACEMENT INDICATOR (ERI) BEHAVIOR AND VVI 65 DURING TRANSTELEPHONIC MONITORING (TTM) BUT WAS NOW SHOWING 1-2 YEARS OF REMAINING LONGEVITY AND NORMAL DDDR OPERATION. THE DEVICE IS STILL IN USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KAPPA 900 DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | KDR901 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other | 5076 IMPLANTABLE PACING LEAD| 5092 IMPLANTABLE PACING LEAD |