FDA Adverse Event
Injury
Summary report: N
PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR
MDR report key: 18555306
·
Received January 22, 2024
Report
- Report Number
- 3006705815-2024-00630
- Event Type
- Injury
- Date Received
- January 22, 2024
- Date of Event
- January 1, 2023
- Report Date
- January 31, 2024
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
- Product Code
- LGW
- UDI-DI
- 05415067031419
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DATE OF EVENT IS ESTIMATED.
Additional Manufacturer Narrative · 0
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem · 0
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2024-00628. RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2024-00588. IT WAS REPORTED THAT THE PATIENT NEVER EXPERIENCED EFFECTIVE THERAPY SHE WANTED. ADDITIONALLY, THE PATIENT EXPERIENCED ZAPPING SENSATION AT THE IPG SITE WITH STIMULATION ON. THE IPG WAS INOPERABLE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2024 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1717975 | PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) | 3660 | A000098855 | 05415067031419 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other | SCS LEAD |