PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR
Report
- Report Number
- 3006705815-2022-18879
- Event Type
- Injury
- Date Received
- December 22, 2022
- Date of Event
- October 14, 2022
- Report Date
- February 13, 2023
- 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
- ME, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED OBSERVATION OF ¿IPG MIGRATION¿ WAS NOT CONFIRMED. THE ELECTRICAL AND MECHANICAL TESTING OF THE DEVICE COULD NOT CONFIRM THE OBSERVATION OF DEVICE MIGRATION. NO X-RAY OF THE DEVICE PRIOR TO EXPLANT WAS PROVIDED. THE HEADER SUTURE ANCHORS WERE INTACT. THE DEVICE WAS SUBJECTED TO A FULL ANALYSIS DUE TO THE ASSOCIATED OBSERVATION UNDER PER- 2022-0162300-01. THE DEVICE WAS SUBJECTED TO A FUNCTIONAL TEST ON AUTOMATED TEST EQUIPMENT (ATE). THIS TESTER VERIFIES THE ELECTRICAL PERFORMANCE OF THE CONTROL/COMMUNICATION CIRCUITRY, AND OUTPUT SIGNAL INTEGRITY. ALL PORTIONS OF ATE TESTING PASSED.
DATE OF EVENT IS ESTIMATED.
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.
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2022-17793. IT WAS REPORTED THE PATIENT'S IPG MIGRATED INSIDE THE POCKET. AS A RESULT, THE PHYSICIAN REVISED THE POCKET AND REPLACED THE IPG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2917044 | PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) | 3660 | A000109442 | 05415067031419 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other | SCS LEAD X2 |