FDA Adverse Event
Malfunction
Summary report: N
KAPPA 400 DR
MDR report key: 2203305
·
Received August 11, 2011
Report
- Report Number
- 2647346-2011-01025
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P970012
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
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 FEELING A VIBRATION APPROXIMATELY 8-10 INCHES BELOW THE PACEMAKER. THE VIBRATION OCCURS EVERY 20-30 MINUTES FOR A FEW SECONDS. FOLLOW-UP FOR FURTHER INFORMATION FROM THE CLINIC WAS PERFORMED WITH NO RESPONSE. 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 | KAPPA 400 DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | KDR401 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Other | 5076 (X2) IMPLANTABLE PACING LEADS |