FDA Adverse Event
Other
Summary report: N
IMPLANTABLE PULSE GENERATOR FOR KNEE PAIN
MDR report key: 17967258
·
Received October 18, 2023
Report
- Report Number
- MW5147116
- Event Type
- Other
- Date Received
- October 18, 2023
- Report Date
- October 18, 2023
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- LGW
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
- Health Professional
- N
Narratives
Description of Event or Problem · 0
REPORTER CALLED TO REPORT THAT SHE RECEIVED A NOTIFICATION LETTER FOR HER IMPLANTED NEUROSTIMULATOR FOR KNEE PAIN (IMPLANTABLE PULSE GENERATOR, IPG). THE NOTIFICATION STATED THAT IF SHE IS SCHEDULED FOR A MAGNETIC RESONANCE IMAGING (MRI) IN THE FUTURE, SHE WILL NEED TO SET HER STIMULATOR INTO MRI MODE. REPORTER STATED THAT SHE IS NOT PRESENTLY ABLE TO GET AN MRI IF SHE NEEDED ONE DUE TO HAVING A PACEMAKER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 178415 | IMPLANTABLE PULSE GENERATOR FOR KNEE PAIN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED F | LGW | ABBOTT MEDICAL | 3660 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female | Other | PACEMAKER |