N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9884493
- MDR report key
- 9884493
- Report number
- 3004209178-2020-06198
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- LISA WOODWARD CLARK
- Address
- 7000 CENTRAL AVENUE NE RCW215 MINNEAPOLIS MN 55432 US
- Phone
- 763-763-7635
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MEDTRONIC PUERTO RICO OPERATIONS CO. | MHY | 37612 | 37612 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-26 | 0 |
Event Narratives#
D
Patient 1
THE PATIENT SERVICES SPECIALIST (PSS) WANTED TO ENSURE EVERYTHING WAS WORKING WITH PATIENT'S THERAPY PER PATIENT'S INITIAL STATEMENT OF "IT" NOT WORKING. PATIENT CONNECTED THE RECHARGER TO THE IMPLANTABLE NEUROSTIMULATOR (INS) AND WAS ABLE TO OBTAIN FULL COUPLING. IT WAS CONFIRMED INS WAS ON. PATIENT NOTED THAT THEIR PARKINSON'S HAD PROGRESSED A LOT WITHOUT MAKING ANY ALLEGATIONS ABOUT THE DEVICE. DURING THE CALL, PATIENT LOST COUPLING AND HAD A HARD TIME REGAINING COUPLING BOXES, WAS ABLE TO GET BACK UP TO 6. PATIENT ALSO NOTED THAT THEIR INS DOES MOVE AROUND INSIDE THE BODY. PATIENT ALSO MENTIONED THAT SHE FELL, AND FELL RIGHT ON TOP OF IT. PATIENT NOTED THAT SHE HAD FALLEN SO MANY TIMES SHE DOESN'T KNOW, BUT THIS ISSUE/FALL WAS PROBABLY ABOUT A YEAR OR 2 AGO. PATIENT ALSO STATED THAT STRESS MAKES HER DYSKINESIA KICK IN, SO PATIENT IS PROBABLY MOVING THE RECHARGER ANTENNA MORE THAN THEY SHOULD BE. PATIENT DID NOT ALLEGE THAT THIS WAS RELATED TO THE DEVICE OR THERAPY. PATIENT WAS REDIRECTED TO THE HEALTH CARE PROVIDER (HCP) TO DISCUSS THE INS MOVING AROUND AND TO HELP WITH CHARGING IN PERSON.
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
D
Patient 1
ADDITIONAL INFORMATION WAS RECEIVED STATING THE FALLS DID NOT AFFECT THE DEVICE/THERAPY.