KIT IMPLANTABLE SLIM TIP LEAD, 90CM
Report
- Report Number
- 1627487-2023-06065
- Event Type
- Injury
- Date Received
- December 21, 2023
- Date of Event
- November 27, 2023
- Report Date
- May 11, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- PMP
- UDI-DI
- 05415067027160
- PMA / PMN Number
- P150004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DATE OF EVENT ESTIMATED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.
DATE OF EVENT ESTIMATED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.
DATE OF EVENT ESTIMATED.
DATE OF EVENT ESTIMATED. DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE DEVICE INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. 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: MN10450-90A, UDI:(B)(4), SERIAL: (B)(6); BATCH: 7113407.
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT SURGICAL INTERVENTION TOOK PLACE WHERE THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THE IGP WAS ELECTIVELY REPLACED. EFFECTIVE STIMULATION WAS RESTORED.
IT WAS REPORTED THAT THE PATIENT DRG LEAD HAD FRACTURED, WHICH WAS CONFIRMED WITH IMAGING., AND AS A RESULT IS EXPERIENCING INEFFECTIVE STIMULATION. SURGICAL INTERVENTION MAY TAKE PLACE AT A FUTURE DATE TO ADDRESS THE ISSUE. 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: MN10450-90A, UDI:(B)(4), SERIAL: (B)(6), BATCH: 7113407.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2035342 | KIT IMPLANTABLE SLIM TIP LEAD, 90CM | DRG LEAD | PMP | ABBOTT MEDICAL | MN10450-90A | 7113407 | 05415067027160 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female | Other | DRG IPG.| DRG LEAD. |