FDA Adverse Event
Injury
Summary report: N
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
MDR report key: 23867325
·
Received December 22, 2025
Report
- Report Number
- 1627487-2025-06297
- Event Type
- Injury
- Date Received
- December 22, 2025
- Date of Event
- August 4, 2025
- Report Date
- March 11, 2026
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- PMP
- UDI-DI
- 05415067027153
- PMA / PMN Number
- P150004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
B3: EVENT DATE IS ESTIMATED.
Additional Manufacturer Narrative · 0
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.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS FEELING JOTS AT THE IPG SITE AND HAD INEFFECTIVE THERAPY. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD ATTRIBUTED TO THIS ISSUE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 AND THE IPG WAS RELOCATED TO A NEW POCKET AND A S1 LEAD WAS ADDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1605472 | KIT IMPLANTABLE SLIM TIP LEAD, 50CM | DRG LEAD | PMP | ABBOTT MEDICAL | MN10450-50A | 10811316 | 05415067027153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Female | Other | DRG LEAD (X2). |