FDA Adverse Event
Malfunction
Summary report: N
KAPPA 900 DR
MDR report key: 1990214
·
Received February 15, 2011
Report
- Report Number
- 2647346-2011-00152
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/014
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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
THE PATIENT REPORTED THAT THERE WAS AN ALLEGED MALFUNCTION, POWER SOURCE PROBLEMS LEADING TO UNDETERMINED LONGEVITY. THE PATIENT ALSO REPORTED HEART RATES ABOVE THE PROGRAMMED RATE AND EPISODES OF SYNCOPE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE 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 | 86 YR | Other | 4092 IMPLANTABLE PACING LEAD| 4574 IMPLANTABLE PACING LEAD |