BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 8906884 · Received August 19, 2019

    Report

    Report Number
    1627487-2019-09401
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    March 1, 2019
    Report Date
    April 6, 2020
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    PMP
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PMA/ 510K NUMBER WAS INADVERTENTLY ENTERED AS P010032 INSTEAD OF P150004 IN INITIAL REPORT. THIS HAS NOW BEEN CORRECTED.

    Additional Manufacturer Narrative · 1

    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 Manufacturer Narrative · 1

    EVENT DATE IS ESTIMATED. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    A PATIENT EXPERIENCING INEFFECTIVE STIMULATION/HIGH IMPEDANCE ON TWO LEADS WAS REPORTED TO ABBOTT. PATIENT HAS HIGH IMPEDANCES ON TWO LEADS. ONE LEAD WAS SWITCHED OFF AND THE OTHER LEAD WAS STILL ON. THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE PATIENTS LEADS WITH HIGH IMPEDANCE WERE EXPLANTED. DURING THE PROCEDURE IT WAS NOTED BOTH LEADS HAD FRACTURES. 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 · 1

    DEVICE 1 OF 2. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-09402.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING FOLLOW UP THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE PATIENTS LEADS WITH HIGH IMPEDANCE WERE EXPLANTED. DURING THE PROCEDURE IT WAS NOTED BOTH LEADS HAD FRACTURES.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-09402. IT WAS REPORTED THE PATIENT WAS INVOLVED IN A CAR ACCIDENT IN (B)(6) 2019 AND THEN BEGAN EXPERIENCING INEFFECTIVE STIMULATION. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON TWO LEADS, AND X-RAYS WERE UNREMARKABLE FOR LEAD MIGRATION. REPROGRAMMING ATTEMPTS HAVE BEEN UNSUCCESSFUL. TO ADDRESS THE ISSUE, THE PHYSICIAN MAY PERFORM SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702223 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG SLIM TIP LEAD PMP ST. JUDE MEDICAL - NEUROMODULATION MN20450-50A AB2436

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DRG LEAD