BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CINCH ANCHOR

    MDR report key: 1637129 · Received March 19, 2010

    Report

    Report Number
    1627487-2010-00183
    Event Type
    Injury
    Date Received
    March 19, 2010
    Date of Event
    January 7, 2010
    Report Date
    February 18, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    K081208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS - THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSIONS - THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 3 OF 3. (SEE MANUFACTURER'S REPORT NUMBERS 1627487-2010-00113 AND 1627487-2010-00181 FOR DEVICES 1 AND 2 RESPECTIVELY). IT WAS REPORTED THAT A PATIENT WITH AN SCS SYSTEM DEVELOPED AN INFECTION ON (B) (6) 2010 AT THE MIDLINE INCISION. THE DOCTOR PRESCRIBED ORAL ANTIBIOTICS FOR THE PATIENT. ON (B) (6) 2010, THE PATIENT'S PERCUTANEOUS LEADS AND ANCHORS WERE EXPLANTED. THE IPG, HOWEVER, WAS LEFT IMPLANTED AS PATIENT WILL BE REIMPLANTED ONCE THE INFECTION CLEARS UP. PATIENT WAS PUT ON ORAL ANTIBIOTICS AFTER THE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CINCH ANCHOR IMPLANTED SCS FOR PAIN RELIEF, ANCHOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 1194 2807989

    Patients

    Seq Age Sex Outcome Treatment
    1 Other