ACTIVA
Report
- Report Number
- 3004209178-2013-02988
- Event Type
- Malfunction
- Date Received
- February 22, 2013
- Report Date
- February 8, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE THERAPY THE DEVICE WAS USED FOR WAS MRU. (B)(4).
PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 3389S-40, LOT# VA02PXP, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3389S-40, LOT# V984308, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; (B)(4).
IT WAS REPORTED THE PATIENT PROGRAMMER DISPLAYED AN "IN THE BOX" ICON MESSAGE. ADDITIONAL INFORMATION RECEIVED 5 DAYS LATER REPORTED THE ISSUE WOULD BE RESOLVED IN THE NEXT WEEK. THE PATIENT WAS DOING WELL WITH NO ISSUES OR COMPLAINTS. THE SYSTEM WAS RECHARGING AND FUNCTIONING PROPERLY. THE PATIENT WAS PLANNED TO HAVE THE DEVICE INTERROGATED BY A CLINICIAN PROGRAMMER TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ISSUE HAD RESOLVED. THE PATIENT HAD "ALWAYS DONE WELL" AND WAS CURRENTLY DOING WELL WITH NO ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78065 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |