FDA Adverse Event
Malfunction
Summary report: N
PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR
MDR report key: 22485364
·
Received July 11, 2025
Report
- Report Number
- 3006705815-2025-05114
- Event Type
- Malfunction
- Date Received
- July 11, 2025
- Date of Event
- June 18, 2025
- Report Date
- August 15, 2025
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
- Product Code
- LGW
- UDI-DI
- 05415067031419
- PMA / PMN Number
- P010032
- Removal / Correction Number
- 1627487-07/07/2023-001-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BASED ON INFORMATION OBTAINED THE DEVICE IS INCLUDED IN THE NEUROMODULATION IMPLANTABLE PULSE GENERATOR (IPG) UNABLE TO EXIT MRI MODE ADVISORY NOTICE ISSUED BY ABBOTT ON 22 JUNE 2023.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT PLACED THE IPG IN MRI AND WAS THEN UNABLE TO DISABLE MRI MODE. A MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT AND WAS ABLE TO SUCCESSFULLY DISABLE THE PATIENT¿S IPG FROM MRI MODE USING AN ORION EXIT TOOL (OET). REPORTEDLY, THERAPY WAS RESTORED.
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERAPY WAS RESTORED AND PATIENT IS ABLE TO CONNECT TO THE IPG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 996887 | PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) | 3660 | A000112261 | 05415067031419 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | SCS LEAD |