KIT IMPLANTABLE SLIM TIP LEAD, 50CM
Report
- Report Number
- 1627487-2023-04713
- Event Type
- Injury
- Date Received
- October 4, 2023
- Date of Event
- September 12, 2023
- Report Date
- December 20, 2023
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- PMP
- UDI-DI
- 05415067027153
- PMA / PMN Number
- P150004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AS A RESULT, A DEVICE HISTORY RECORD WAS PERFORMED TO REVIEW AND CONFIRM THE STERILITY OF DEVICES. BASED ON THE DOCUMENTS REVIEWED, THE SOURCE OF THE INFECTION REMAINS UNKNOWN.
DATE OF EVENT ESTIMATED. THE ALLEGATION IS AGAINST [1] OF [2] [LEAD]; HOWEVER, IT IS UNKNOWN WHICH [LEAD(S)], THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8830818.
IT WAS REPORTED THAT DURING A LEAD EXPLANT PROCEDURE THE PATIENT WAS TREATED WITH ANTIBIOTICS AND A DRAINAGE BAG. THE PHYSICIAN WANTED TO TAKE PROACTIVE MEASURES DUE TO THE PATIENT COULD HAVE A POSSIBLE INFECTION. THE MANUFACTURE REPRESENTATIVE WILL RECEIVE UPDATES FROM THE PHYSICIAN IF FURTHER INTERVENTION IS REQUIRED. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT. THE ALLEGATION IS AGAINST [1] OF [2] [LEAD]; HOWEVER, IT IS UNKNOWN WHICH [LEAD(S)], THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8830818.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 589811 | KIT IMPLANTABLE SLIM TIP LEAD, 50CM | DRG LEAD | PMP | ABBOTT MEDICAL | MN10450-50A | 8830818 | 05415067027153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Male | Other | DRG IPG |