BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 3172491 · Received June 17, 2013

    Report

    Report Number
    3005099803-2013-05383
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT ALSO LISTED THE FOLLOWING PHYSICIAN ASSOCIATED WITH (B)(6).

    Description of Event or Problem · 1

    THIS REPORT PERTAINS TO TWO OF THREE DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT # 3005099803-2013-05386 AND MANUFACTURER REPORT # 3005099803-2013-04549 PERTAIN TO THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PINNACLE ANTERIOR-APICAL PELVIC FLOOR REPAIR KIT WAS IMPLANTED (B)(6) 2009. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ACCORDING TO THE PHYSICIAN'S OFFICE, THE PATIENT HAS NOT FOLLOWED-UP WITH ANY COMPLAINTS OR COMPLICATIONS. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274103 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317050

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT| OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM