ACTIVA
Report
- Report Number
- 3004209178-2013-01012
- Event Type
- Injury
- Date Received
- January 28, 2013
- Report Date
- January 8, 2013
- 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 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V705412, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V705412, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).
THIS WAS A BILATERAL SYSTEM. REFERENCE MFR 3004209178-2013-01011.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S SURGERY WENT WELL. IT WAS NOTED THE PATIENT WAS A 'MEDICALLY DIFFICULT PATIENT.'
IT WAS REPORTED THE PATIENT WAS HAVING 'SOME ADVERSE EVENTS' FROM THE STIMULATION. IT WAS UNCLEAR IF THE LEAD OR DEVICE WAS RESPONSIBLE FOR THESE 'EVENTS.' A REVISION/REPOSITIONING OF THE LEAD WAS SCHEDULED FOR (B)(6) 2013. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. REFER TO MANUFACTURER REPORT #3004209178-2013-01011. THE PATIENT HAS TWO SYSTEMS AND IT WAS UNCLEAR WHICH LEAD FROM WHICH SYSTEM WAS TO BE REVISED, OR IF BOTH WERE TO BE REVISED.
FOLLOWING ADDITIONAL REVIEW IT WAS FOUND THAT THERE WAS SOME THOUGHT THAT THE LEAD NEEDS TO BE MOVED A BIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37255 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |