BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLIA S 53

    MDR report key: 3160145 · Received June 10, 2013

    Report

    Report Number
    1028232-2013-01629
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 31, 2013
    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

    THE RETURNED ELECTRODE WAS PRESENT ONLY IN FRAGMENTS . ALL PARTS OF THE ELECTRODE WERE RETURNED FOR ANALYSIS . THE MORPHOLOGY OF THE CUT SURFACE INDICATES THAT THE DIVISION OF THE ELECTRODE HAS PROBABLY OCCURRED IN CONNECTION WITH THE EXPLANT .IN THE VISUAL INSPECTION OF A DEFORMED FIXING SCREW HAS BEEN IDENTIFIED. THE ANALYSIS SHOWED THAT THE CAUSE IS PROBABLY DUE TO THE MECHANICAL STRESS DURING THE OPERATION. DURING THE ONGOING ANALYSIS SHOWED NO FURTHER DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS , WHICH MIGHT BE RELATED TO THE CLINICAL COMPLAINT. IN SUMMARY, A DEFORMATION OF THE FIXING SCREW WAS FOUND THAT IMPAIRED THE FUNCTIONING OF THE ACTIVE FIXATION. THERE WAS NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT THE LEAD BECAME DISLODGED ABOUT 1 MONTH AFTER THE IMPLANTATION. SIX DAYS AFTER THE LEAD REVISION, A NEW DISLODGEMENT WAS REPORTED. NO DETERIORATION OF THE PATIENT'S STATE OF HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261321 SOLIA S 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 377177

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization