KINETRA
Report
- Report Number
- 3004209178-2012-10649
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Report Date
- October 26, 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
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT ID, 748240 SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 748240 SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7436 SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3387S-40 LOT# V030671 IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3387S-40 LOT# V012262, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD. (B)(4).
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SURGE DURING RADIOWAVE ELECTROCAUTERY FOR THE REMOVAL OF SKIN CANCER FROM HIS FACE. THERE WAS NO ISSUE WITH THE DEVICE. THE PATIENT WAS GOING TO HAVE THE DEVICE REPLACED ON 2012 (B)(6) FOR "BATTERY". THERE WERE NO SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. PATIENT'S HEALTHCARE PROVIDER (HCP) SAW THE PATIENT IN THE CLINIC ON (B)(6)-2012 AND THE PATIENT DID NOT REPORT THIS INCIDENT DURING THE VISIT. IMPEDANCE VALUES WERE UNKNOWN SINCE THE NEUROSTIMULATOR HAD BEEN REPLACED ON (B)(6)-2012 DUE TO "END OF BATTERY LIFE, NOT DUE TO THIS INCIDENT." THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND DID NOT SUSTAIN ANY INJURY.
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 |