KIT IMPLANTABLE SLIM TIP LEAD, 50CM
Report
- Report Number
- 1627487-2024-00035
- Event Type
- Injury
- Date Received
- January 5, 2024
- Date of Event
- October 1, 2023
- Report Date
- May 2, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- PMP
- UDI-DI
- 05415067027153
- PMA / PMN Number
- P150004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A PATIENT IS EXPERIENCED INEFFECTIVE THERAPY WAS REPORTED TO ABBOTT. AS A RESULT, THE PATIENT'S SYSTEM WAS EXPLANTED. 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 EVENT COULD NOT BE CONCLUSIVELY DETERMINED.
DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI:(B)(4), SERIAL: (B)(6), BATCH: 6151565.
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 IS EXPERIENCING INEFFECTIVE THERAPY. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT.
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2024 WHEREIN THE PATIENT'S DRG SYSTEM WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655111 | KIT IMPLANTABLE SLIM TIP LEAD, 50CM | DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF | PMP | ABBOTT MEDICAL | MN10450-50A | 6151565 | 05415067027153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | DRG IPG (X1)| DRG LEAD (X1) |