N
Patient 1
DEVICE REMAINS IMPLANTED.
MAUDE MDR 6504798
- MDR report key
- 6504798
- Report number
- 3005025697-2017-00011
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-03-23
- Date received
- 2017-04-19
- 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
- DR. KATHERINE TWEDEN
- Address
- 2800 PATTON ROAD SAINT PAUL MN 55113 US
- Phone
- 651-651-6516
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MAESTRO RECHARGEABLE SYSTEM | RECHARGEABLE NEUROREGULATOR | ENTEROMEDICS, INC. | PIM | 2002 | 2002 | 093G29714 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-04-19 | 0 | 1. R |
Event Narratives#
D
Patient 1
THIS PATIENT UNDERWENT IMPLANTATION OF THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2015. AN UNANTICIPATED SHUTDOWN EVENT OF THE RECHARGEABLE NEUROREGULATOR (RNR) WAS REPORTED ON (B)(6) 2017. MULTIPLE ATTEMPTS TO RESET THE REAL TIME CLOCK, CLEAR THE UNINTENDED SHUTDOWN ERROR CODE, AND RECONNECT THE BATTERY IN THE RNR WERE UNSUCCESSFUL. THERAPY DELIVERY COULD NOT BE RE-ESTABLISHED.