BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFIO S 53

    MDR report key: 4211038 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-003828
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 17, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS DESTROYED IN THE RETURNED STATE. THE LEAD HAD BEEN CUT THROUGH 5 CM DISTAL OF THE IS-1 CONNECTOR PIN, PROBABLY WITH A SCALPEL. BOTH FRAGMENTS WERE AVAILABLE FOR ANALYSIS. THE INNER CONDUCTOR COIL WAS KINKED BETWEEN SCREW HEAD AND RING ELECTRODE. THE DEFORMED INNER CONDUCTOR COIL IS PROBABLY A RESULT OF THE MECHANICAL STRESS DURING THE IMPLANTATION. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Description of Event or Problem · 1

    OUS MDR - SCREW HAS NO HOLD IN THE TISSUE, THIS LEAD DISLODGED AFTER ABOUT 24 H. SEVERAL REPOSITIONING ATTEMPTS IN VARIOUS POSITIONS WERE UNSUCCESSFUL AND LED TO CAPPING OF END PIECE FOR INTRODUCER PLACEMENT. AT FIRST NO TISSUE RESIDUE COULD BE DETECTED IN THE SCREW. THEN ANOTHER LEAD WAS ATTEMPTED WITH ABOUT 15 POSITIONING ATTEMPTS AT VARIOUS SITES. WHEN THE STYLET IS WITHDRAWN, THE LEAD ALWAYS DISLODGES. SCREW TURNS WITH DIFFICULTY, SOMETIMES JUMPY, AND ONLY FROM >25 ROTATIONS ON. A 3RD LEAD WAS FINALLY SUCCESSFULLY IMPLANTED AFTER ABOUT 10 ATTEMPTS. SCREW ALSO SEEMED JUMPY AND HARD TO RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691660 SAFIO S 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 370945

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization