BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 8804355 · Received July 18, 2019

    Report

    Report Number
    3010291427-2019-00002
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    July 1, 2019
    Report Date
    July 18, 2019
    Manufacturer
    AVAILMED S.A.DE C.V.9
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROVIDER VIA THE MANUFACTURER REPRESENTATIVE REPORTING THAT DURING A PNE TEST, THE PHYSICIAN TRIED TO REMOVE THE STYLET BUT FOUND A MECHANICAL RESISTANCE. IN ORDER TO EXTRACT THE STYLET, THE PHYSICIAN PULLED IT HARDER AND THE STYLET BROKE. THE PHYSICIAN DISCARDED THE STYLET AND NEEDLE. IT WAS UNKNOWN IF THERE WERE ANY EXTERNAL CONTRIBUTING FACTORS. NO DIAGNOSTICS/TROUBLESHOOTING WAS PERFORMED. NO INTERVENTIONS/ACTIONS WERE TAKEN. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. NO SURGICAL INTERVENTION OCCURRED NOR WAS PLANNED. THE PATIENT WAS ALIVE WITH NO INJURY. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596414 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AVAILMED S.A.DE C.V.9 309101 0217752887

    Patients

    Seq Age Sex Outcome Treatment
    1