FDA Adverse Event
Injury
Summary report: N
ACTIVA
MDR report key: 5298855
·
Received December 15, 2015
Report
- Report Number
- 2649622-2015-15940
- Event Type
- Injury
- Date Received
- December 15, 2015
- Report Date
- November 25, 2015
- Manufacturer
- MPRI
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID 3387S-40, LOT # VA0Z59J, IMPLANTED: (B)(6) 2015, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THE IMPLANT SURGERIES WERE UNCOMFORTABLE, PARTICULARLY DURING THE LEAD PLACEMENT AFTER BEING INJECTED WITH A PAIN KILLER. THEY SAW ANIMALS/GOATS/IMAGES/LIFE FLASHING BEFORE HIM AND HAD STRANGE DREAMS. THEY WERE HAPPY WITH THE THERAPY RESULTS. ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THEY PATIENT WAS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 827554 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MPRI | 3387S-40 | VA0Z59J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00063 YR | Other |