FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1851111
·
Received September 30, 2010
Report
- Report Number
- 1644487-2010-02202
- Event Type
- Injury
- Date Received
- September 30, 2010
- Date of Event
- September 1, 2010
- Report Date
- November 12, 2021
- Manufacturer
- LIVANOVA USA, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT CAN NO LONGER FEEL STIMULATION AND BELIEVES THE DEVICE MAY NOT BE WORKING. THE PATIENT IS EXPERIENCING AN INCREASE IN DEPRESSION. THE PHYSICIAN WHO SAW THE PATIENT WAS ABLE TO INTERROGATE THE PATIENT'S DEVICE AFTER MULTIPLE TRIES. THE PHYSICIAN REFERRED THE PATIENT FOR A SURGICAL CONSULT. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | MUZ | LIVANOVA USA, INC. | 102 | 015030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Required Intervention |