BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 11145640 · Received January 11, 2021

    Report

    Report Number
    1627487-2021-00216
    Event Type
    Injury
    Date Received
    January 11, 2021
    Date of Event
    December 21, 2020
    Report Date
    February 3, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: (B5) THE CORRECT RELATED MFR REPORT# WAS LISTED INCORRECTLY ON THE INITIAL REPORT. THE CORRECT RELATED MFR REPORT# HAS BEEN PROVIDED. 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.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). ADDITIONAL INFORMATION RECEIVED REVEALED THE PATIENT UNDERWENT SURGICAL INTERVENTION. DURING THE PROCEDURE, THE PATIENT'S RIGHT L1 LEAD WAS EXPLANTED AND REPLACED. THE PATIENT'S LEFT L1 LEAD WAS UNABLE TO BE EXPLANTED DUE TO THE PATIENT'S ANATOMY. IN TURN, THE DOCTOR DECIDED TO CUT THE LEFT L1 LEAD AND LEFT IT INSIDE THE PATIENT. THE DOCTOR ALSO DECIDED TO IMPLANT ANOTHER L1 LEAD ON THE PATIENT'S LEFT SIDE. NOTE: BOTH OF THE PATIENT'S LEADS ARE BEING REPORTED AS EXPLANTED BECAUSE IT UNKNOWN WHICH LEAD WAS THE PATIENT'S RIGHT L1 LEAD THAT WAS REPLACED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT. DURING THE PROCESSING OF THIS INCIDENT ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-002167. IT WAS REPORTED THAT DESPITE THE AMPLITUDE BEING INCREASED TO 5MA, THE PATIENT WAS UNABLE TO FEEL STIMULATION. THE ISSUE OCCURRED WHEN INCREASING STIMULATION FOR THE LEADS LOCATED AT THE L1 VERTEBRAL LEVEL. PHYSICIAN REVIEWED IMAGING OF THE LEADS AND NO ANOMLAIES WERE NOTED. SURGICAL INTERVENTION IS SLATED TO TAKE PLACE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47398 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG SLIM TIP LEAD PMP ABBOTT MEDICAL MN10450-50A 6554206 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 Other KIT IMPLANTABLE SLIM TIP LEAD, 50CM| KIT IMPLANTABLE SLIM TIP LEAD, 50CM