FDA Adverse Event
Injury
Summary report: N
KAPPA 400 DR
MDR report key: 2791297
·
Received October 15, 2012
Report
- Report Number
- 6000144-2012-05340
- Event Type
- Injury
- Date Received
- October 15, 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
- MI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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). PRELIMINARY TESTING REVEALED NO OUTPUT AND NO TELEMETRY. THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHECK, THE PATIENT COMPLAINED OF BEING TIRED AND THE PATIENT WAS NOTED TO HAVE INTERVALS OF BRADYCARDIA. THE PHYSICIAN WAS UNABLE TO ESTABLISH TELEMETRY. THERE WAS NO MAGNET RESPONSE AND NO PACING SPIKES WERE SEEN. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE NOTED 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 | 92 YR | Hospitalization| R | 5076 X2 IMPLANTABLE PACING LEADS |