N
Patient 1
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 6301243
- MDR report key
- 6301243
- Report number
- 3004209178-2017-02533
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-01-20
- Date received
- 2017-02-03
- 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 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. | MFR | 37612 | 37612 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-02-03 | 0 | 1. R |
Event Narratives#
D
Patient 1
INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE, HEALTHCARE PROVIDER AND THE PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR OBSESSIVE COMPULSIVE DISORDER AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT WAS HAVING POOR COUPLING WITH THE DEVICE ON THEIR LEFT SINCE (B)(6) 2017. THE PATIENT ATTEMPTED TO RESOLVE THE ISSUE USING THE ANTENNA LOCATE FEATURE BUT IT DID NOT RESOLVE THE ISSUE. THE PATIENT REPORTED THAT THEY DID NOT HAVE ANY BANDAGES OR SWELLING THAT MAY HAVE BEEN CAUSING THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017. ONE OF THE PATIENTS HEALTHCARE PROVIDERS REPORTED SEEING AN ?ELECTIVE REPLACEMENT INDICATOR? (ERI) MESSAGE ON THE PATIENTS RECHARGER A FEW DAYS PRIOR, EVEN THOUGH THE PATIENT HAD THE DEVICES IMPLANTED ON (B)(6) 2017. THE NURSE AND THE MANUFACTURING REPRESENTATIVE WERE NOT ABLE TO REPLICATE THIS MESSAGE ON THE RECHARGER OR ON THE PATIENT PROGRAMMER. THE PATIENT HAS NO ISSUE WITH COUPLING ON THEIR RIGHT INS BUT IS ONLY GETTING 2 BARS COUPLING ON THE LEFT INS. THE PATIENT?S NURSE ORDERED FOR IMAGES TO BE TAKEN OF THE DEVICE. THE IMAGES SHOWED THAT THE PATIENT?S INS WAS FLIPPED IN THE POCKET. THE PATIENT DECIDED THAT THEY DID NOT WANT TO GO BACK INTO SURGERY TO FIX THE ISSUE, AND WILL INSTEAD BE MORE DILIGENT ABOUT RECHARGING THE INS WITH ONLY 2 COUPLING BARS. THERE WERE NO PATIENT SYMPTOMS REPORTED.
N
Patient 1
D
Patient 1
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE. IT WAS REPORTED THAT THE CAUSE OF THE INS FLIP REMAINS UNKNOWN.
N
Patient 1
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
D
Patient 1
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THEY HAD THE INS SUTURED IN AGAIN. THERE ARE NO FURTHER PROBLEMS.
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.