KINETRA
Report
- Report Number
- 3007566237-2012-02984
- Event Type
- Injury
- Date Received
- December 11, 2012
- Report Date
- November 20, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40, LOT# V022878, IMPLANTED: 2007-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3387S-40, LOT# V021585, IMPLANTED: 2007-(B)(6), EXPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD. (B)(4).
IT WAS REPORTED THAT THE PATIENT HAD A REVISION FOR HIS DEEP BRAIN STIMULATOR (DBS). IT WAS UNKNOWN IF THE REVISION WAS ON THE DEVICE OR A CONTAMINANT PRODUCT. THE DATE, CAUSE OF THE EVENT, AND PATIENT OUTCOME WERE UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS UNAVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A LEAD REVISION. IT WAS STATED THAT THERE WAS NOTHING WRONG WITH THE LEADS, EXCEPT SOME IMPEDANCE ISSUES, BUT THE PROCEDURE WAS DONE AT THE INSISTENCE OF THE PATIENT BECAUSE HE WAS UNHAPPY WITH THE RESULTS AND EFFICACY OF THE THERAPY. IT WAS STATED THAT AFTER THE LEAD REPLACEMENT THE PATIENT WAS "HAPPIER" AND THAT HE "TOLERATED" THE PROCEDURE "FINE". THERE WAS NO FURTHER INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |