KIT IMPLANTABLE SLIM TIP LEAD, 50CM
Report
- Report Number
- 1627487-2025-00744
- Event Type
- Injury
- Date Received
- February 18, 2025
- Date of Event
- January 4, 2025
- Report Date
- March 28, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- PMP
- UDI-DI
- 05415067027153
- PMA / PMN Number
- P150004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTED B5 TEXT.
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. THE ALLEGATION IS AGAINST 1 OF 2 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS OCTRODE LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6853912.
ADDITIONAL INFORMATION INDICATES THAT LEAD WAS REPLACED TO ADDRESS THE ISSUE.
ADDITIONAL INFORMATION INDICATES THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2025.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. DIAGNOSTIC TESTING REVEALED HIGH IMPEDANCE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD CONTRIBUTED TO THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2572974 | KIT IMPLANTABLE SLIM TIP LEAD, 50CM | DRG LEAD | PMP | ABBOTT MEDICAL | MN10450-50A | 6853912 | 05415067027153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other | DRG IPG| DRG LEAD |