PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR
Report
- Report Number
- 1627487-2024-09699
- Event Type
- Injury
- Date Received
- July 7, 2024
- Date of Event
- June 1, 2024
- Report Date
- April 28, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- LGW
- UDI-DI
- 05415067020222
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
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.
IT WAS REPORTED THAT THE PATIENT'S IPG BECAME INOPERABLE AFTER AN UNRELATED PROCEDURE WHERE THE IPG WAS NOT SET TO SURGERY MOE. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. AS A RESULT, THE PATIENT MAY UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025 WHERE THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE STIMULATION WAS RESTORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 901227 | PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR | SCS IPG | LGW | ABBOTT MEDICAL | 3662 | 6379085 | 05415067020222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other | SCS LEAD |