FDA Adverse Event
Injury
Summary report: N
KAPPA 900 DR
MDR report key: 3398182
·
Received October 9, 2013
Report
- Report Number
- 3004209178-2013-17888
- Event Type
- Injury
- Date Received
- October 9, 2013
- Report Date
- July 7, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- DXY
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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. CONCOMITANT PRODUCTS: 4574 IMPLANTABLE PACING LEAD IMPLANTED: (B)(6) 2005-08-21, 4074 IMPLANTABLE PACING LEAD IMPLANTED: (B)(6) 2005. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO EMERGENCY ROOM (ER) WITH HYPOTENSION AND COMPLETE A/V BLOCK WITH VENTRICULAR RATES LESS THAN 40BPM. THE DOCTOR APPLIED A MAGNET TO THE DEVICE AND NO MAGNET RESPONSE OCCURRED. THERE WERE NO PACEMAKER SPIKES PRESENT ON SURFACE ELECTROCARDIOGRAM (ECG) AND NO TELEMETRY WITH THE PROGRAMMER. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 512871 | KAPPA 900 DR | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | KDR901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00083 YR | Hospitalization| R |