FDA Adverse Event
Injury
Summary report: N
PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR
MDR report key: 18446598
·
Received January 4, 2024
Report
- Report Number
- 1627487-2024-00092
- Event Type
- Injury
- Date Received
- January 4, 2024
- Date of Event
- December 14, 2023
- Report Date
- March 6, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- LGW
- UDI-DI
- 05415067020222
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DAE OF EVENT IS ESTIMATED. FURTHER INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.
Additional Manufacturer Narrative · 0
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.
Description of Event or Problem · 0
IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Description of Event or Problem · 0
ADDITIONAL INFORMATION INDICATES THAT SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN IPG WAS REPOSITIONED TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655168 | PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR | SCS IPG | LGW | ABBOTT MEDICAL | 3662 | 6070222 | 05415067020222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other | SCS LEAD |