FDA Adverse Event
Injury
Summary report: N
KAPPA 400 DR
MDR report key: 2051833
·
Received April 12, 2011
Report
- Report Number
- 2647346-2011-00486
- Event Type
- Injury
- Date Received
- April 12, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P970012
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 BEING "BREATHLESS". THE PATIENT ALSO NOTED NOT USING THE PACEMAKER ANY MORE AND BEING TOLD THAT THE DEVICE COULD NOT BE SHUT OFF. FOLLOW-UP WAS CONDUCTED TO OBTAIN INFORMATION ON WHETHER THE EPISODE WAS DEVICE RELATED, BUT THE ATTEMPTS WERE UNSUCCESSFUL. RECORDS INDICATE 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 400 DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | KDR401 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other | 5076 X2 IMPLANTABLE PACING LEAD |