FDA Adverse Event
Injury
Summary report: N
KAPPA
MDR report key: 2955585
·
Received February 11, 2013
Report
- Report Number
- 1030489-2013-00435
- Event Type
- Injury
- Date Received
- February 11, 2013
- Report Date
- December 12, 2012
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- DXY
- PMA / PMN Number
- P980035
- 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS NOT ABLE TO BE INTERROGATED AND IT DOES NOT RESPOND TO MAGNET APPLICATION. THE DEVICE WILL BE REMOVED AND REPLACED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59030 | KAPPA | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | MDT SOFAMOR DANEK PUERTO RICO MFG | KDR901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | 5076 IMPLANTABLE PACING LEAD |