KIT IMPLANTABLE SLIM TIP LEAD, 50CM
Report
- Report Number
- 1627487-2024-07367
- Event Type
- Injury
- Date Received
- March 6, 2024
- Date of Event
- February 6, 2024
- Report Date
- October 28, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- PMP
- UDI-DI
- 05415067027153
- PMA / PMN Number
- P150004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DATE OF EVENT ESTIMATED.
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: 9042817.
DATE OF EVENT ESTIMATED. CORRECTION: SECTION B5 CML VEBIAGE WAS INADVERTENTLY ADDED ON THE INITIAL REPORT. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS.
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.
ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WAS EXPERIENCING SHOCKING AT THE IPG SITE. SURGICAL INTERVENTION TOOK PLACE WHERE THE IPG AND LEAD WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE STIMULATION WAS RESTORED.
IT WAS REPORTED THAT THE DEVICE COULD NOT DELIVER THE DESIRED STRENGTH. UPON FURTHER INVESTIGATION THE SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES ON THE LEAD AND THAT THE LEAD HAD MIGRATED, WHICH WAS CONFIRMED VIA X-RAY. AS A RESULT, THE PATIENT 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: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9042817.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 118378 | KIT IMPLANTABLE SLIM TIP LEAD, 50CM | SCS LEAD | PMP | ABBOTT MEDICAL | MN10450-50A | 9042817 | 05415067027153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other | SCS IPG| SCS LEAD |