FDA Adverse Event
Injury
Summary report: N
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
MDR report key: 15550671
·
Received October 6, 2022
Report
- Report Number
- 1627487-2022-05432
- Event Type
- Injury
- Date Received
- October 6, 2022
- Date of Event
- September 19, 2022
- Report Date
- October 6, 2022
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- PMP
- UDI-DI
- 05415067027153
- PMA / PMN Number
- P150004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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 SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(4), BATCH: 8081922.
Description of Event or Problem · 0
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE STIMULATION WITH THEIR DRG SYSTEM. IN TURN, REPROGRAMMING WAS UNSUCCESSFUL IN RECTIFYING THE ISSUE. X-RAYS CONFIRMED THAT THE LEADS HAVE NOT MIGRATED. AS A RESULT, SURGICAL INTERVENTION TO REVISE OR REPLACE THE LEADS MAY OCCUR IN THE FUTURE TO REMEDY THE ISSUE. IT IS UNCLEAR WHICH LEAD CONTRIBUTED TO THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2799945 | KIT IMPLANTABLE SLIM TIP LEAD, 50CM | DRG SLIM TIP LEAD | PMP | ABBOTT MEDICAL | MN10450-50A | 8081922 | 05415067027153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other | DRG IPG| DRG LEAD |