KIT IMPLANTABLE SLIM TIP LEAD, 50CM
Report
- Report Number
- 1627487-2024-07937
- Event Type
- Injury
- Date Received
- April 4, 2024
- Date of Event
- March 12, 2024
- Report Date
- July 30, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- PMP
- UDI-DI
- 05415067027368
- PMA / PMN Number
- P150004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG LEAD, MODEL: MN20450-50A , UDI:(B)(6), SERIAL: (B)(6), BATCH:9171081
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. THE DEVICE HISTORY RECORD OF THE DEVICE WAS REVIEWED TO CONFIRM THAT ALL MANUFACTURING STEPS WERE COMPLETED AND THERE WERE NO NON-CONFORMANCES NOTED THAT COULD HAVE CONTRIBUTED TO THIS ISSUE.
ADDITIONAL INFORMATION WAS RECEIVED INDICATING SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IMPEDED LEADS WERE EXPLANTED AND REPLACED TO RESOLVE THE ISSUE
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-07938 IT WAS REPORTED THAT THE PATIENT EXPERIENCED I(B)(4)NEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON TWO OF THE LEADS. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH TWO LEADS HAD HIGH IMPEDANCES.
INFORMATION INDICATES THAT THE LEADS HAD MIGRATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63191 | KIT IMPLANTABLE SLIM TIP LEAD, 50CM | DRG LEAD | PMP | ABBOTT MEDICAL | MN20450-50A | 9171081 | 05415067027368 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other | DRG LEAD |