FDA Adverse Event
Injury
Summary report: N
KAPPA 400 DR
MDR report key: 2791177
·
Received October 15, 2012
Report
- Report Number
- 2647346-2012-01721
- Event Type
- Injury
- Date Received
- October 15, 2012
- Date of Event
- August 27, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P970012
- Removal / Correction Number
- Z-2120-2011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD SYNCOPE AND PRESENTED TO THE EMERGENCY ROOM. THE DEVICE COULD NOT BE INTERROGATED AND A MAGNET RESPONSE COULD NOT BE SOLICITED. THE DEVICE WAS THOUGHT TO BE AT END OF LIFE. IT WAS ALSO NOTED THAT THE PATIENT HAD NOT BEEN SEEN FOR FOLLOW UP SINCE THE DEVICE WAS IMPLANTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER 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. | KDR401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| L| R | 330-801 COMPETITOR IMPLANTABLE PACING LEAD| 330-258 COMPETITOR IMPLANTABLE PACING LEAD |