N
Patient 1
PERCEPT INS IS NOT APPROVED IN US AT THIS TIME, BUT IS SIMILAR TO DEVICES APPROVED UNDER MHY. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9908227
- MDR report key
- 9908227
- Report number
- 3004209178-2020-06478
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-05
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- 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 | PERCEPT | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MEDTRONIC PUERTO RICO OPERATIONS CO. | MHY | B35200 | B35200 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING ELECTRICAL SENSATIONS AROUND THE INS SITE. AFTER IMPLANT THE IMPEDANCE MEASUREMENTS WERE ALL NORMAL, BUT ONE DAY LATER THE SENSATIONS BEGAN AND IMPEDANCE WAS MEASURED TO BE 40 OHMS TOO HIGH, SLIGHTLY OUT OF RANGE. NO TRUE TROUBLESHOOTING HAD BEEN PERFORMED OTHER THAN SEVERAL IMPEDANCE CHECKS. THE CAUSE WAS NOT DEFINITIVELY DETERMINED, BUT IT WAS STATED THERE WAS "PROBABLY SOME FLUID WITHIN THE INS AND EXTENSION." A REVISION SURGERY TO DE- AND RECONNECT THE EXTENSION AND INS WAS PROPOSED, BUT THE SENSATIONS HAD BEEN BECOMING WEAKER. THE PATIENT DECIDED TO WAIT SOME DAYS/WEEKS AND IF THERE WAS FURTHER IMPROVEMENT, NO REVISION WOULD BE PERFORMED.