FDA Adverse Event
Injury
Summary report: N
KAPPA 400 DR
MDR report key: 1922252
·
Received December 13, 2010
Report
- Report Number
- 2647346-2010-00832
- Event Type
- Injury
- Date Received
- December 13, 2010
- 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
- MA, US
- Reporter Occupation
- PHYSICIAN
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. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAS TRIPPED THE ELECTIVE REPLACEMENT INDICATOR AND HAS EXPERIENCED A POWER ON RESET. THE PATIENT, WHO WAS LOST TO FOLLOW-UP, REPORTED A RECENT HOSPITAL VISIT WHERE THEY WERE EXTERNALLY DEFIBRILLATED. NO PATIENT COMPLICATIONS HAVE BEEN 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. | KDR403 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Hospitalization| R | 4024 IMPLANTABLE PACING LEAD| 4568 IMPLANTABLE PACING LEAD |