BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT LOW IMPEDANCE LEAD

    MDR report key: 2152267 · Received June 23, 2011

    Report

    Report Number
    6000153-2011-04712
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MPROC, VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TESTING OF THE LEADS (MODEL 3778, (B)(4)) REVEALED NO ANOMALIES. THE LEADS HAD ACCEPTABLE CONTINUITY AND NO SHORTS. THE RETURNED STYLET AND A KNOWN GOOD STYLET COULD BE INSERTED AND REMOVED WITH NO ISSUES. THE LEADS WERE FUNCTIONALLY OKAY. TESTING OF THE STYLET (MODEL STYLET/STIM, SERIAL NUMBER UNKNOWN) REVEALED NO SIGNIFICANT ANOMALIES. THE STYLET WIRE WAS BENT 14 CM FROM THE PROXIMAL END.

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL WAS UNABLE TO INSERT ANY STYLETS INTO TWO LEADS DURING IMPLANT. THE STYLETS WERE CLEANED, BUT STILL COULD NOT BE INSERTED. TWO NEW LEADS WERE USED TO COMPLETE THE IMPLANT. THE PATIENT RECOVERED WITHOUT SEQUELA. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. SEE ALSO MANUFACTURER'S REPORT #6000153-2011-04710.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT LOW IMPEDANCE LEAD LGW MPROC, VILLALBA 3778 V11026443

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| LEAD: MODEL 3778, LOT# V639156031| EXPLANTED:| STIM ACCESSORY: MODEL STYLET/STIM, LOT# UNKNOWN