BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 3983064 · Received August 6, 2014

    Report

    Report Number
    3005099803-2014-02734
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    PMA / PMN Number
    K071957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF SUTURE DETACHMENT. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PFR KIT - PINNACLE, ANTERIOR APICAL WAS USED DURING A MESH REPAIR PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, WHILE THE PHYSICIAN WAS PULLING THE SUTURE AND DILATOR THROUGH THE SACROSPINOUS LIGAMENT, THE SUTURE BROKE. NOTHING WAS LEFT BEHIND INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PFR KIT - PINNACLE, ANTERIOR APICAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460970 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, SYNTHETIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068317050 ML00001456

    Patients

    Seq Age Sex Outcome Treatment
    1