KIT IMPLANTABLE SLIM TIP LEAD, 50CM
Report
- Report Number
- 1627487-2024-07348
- Event Type
- Injury
- Date Received
- March 5, 2024
- Date of Event
- February 16, 2024
- Report Date
- April 8, 2024
- 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
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
SECTION A4: DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN PATIENT WEIGHT. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. SECTION B3: 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: DRG LEAD, MODEL: MN10450-50A, UDI:(B)(4), SERIAL:(B)(6), BATCH:8830818.
B1 - CHECKED PRODUCT PROBLEM WHICH WAS MISSED IN THE INITIAL REPORT. 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 PATIENT EXPERIENCED AUTO REDUCING OF THE RIGHT S1 LEAD. DIAGNOSTICS INDICATED THAT EVERY CONTACT ON THAT LEAD HAD HIGH IMPEDANCES. AS SUCH, SURGICAL INTERVENTION IS PENDING TO ADDRESS THE ISSUE.
ADDITIONAL INFORMATION RECEIVED INDICATED THAT PATIENT UNDERWENT SURGICAL INTERVENTION WHERE THE RIGHT S1 LEAD WAS REPLACED, AND THERAPY WAS RESTORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175948 | KIT IMPLANTABLE SLIM TIP LEAD, 50CM | DRG LEAD | PMP | ABBOTT MEDICAL | MN10450-50A | 8830818 | 05415067027153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other | DRG IPG| DRG LEAD X 3 |