KIT IMPLANTABLE SLIM TIP LEAD, 50CM
Report
- Report Number
- 1627487-2024-08628
- Event Type
- Injury
- Date Received
- May 8, 2024
- Date of Event
- April 20, 2024
- Report Date
- June 4, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- PMP
- UDI-DI
- 05415067027153
- PMA / PMN Number
- P150004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN PATIENT WEIGHT. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. EVENT DATE IS ESTIMATED. THE ALLEGATION IS AGAINST ONE OF FOUR LEADS; HOWEVER, IT IS UNKNOWN WHICH LEADS, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8830818 COMMON DEVICE NAME: SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9054571 COMMON DEVICE NAME: SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9054571.
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE RELIEF FROM THEIR DRG SYSTEM. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.
ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT'S SYSTEM WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 758993 | KIT IMPLANTABLE SLIM TIP LEAD, 50CM | DRG LEAD | PMP | ABBOTT MEDICAL | MN10450-50A | 8713231 | 05415067027153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other | DRG IPG (X1)| DRG LEAD (X3) |