BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CINCH LEAD ANCHOR

    MDR report key: 2031334 · Received March 23, 2011

    Report

    Report Number
    1627487-2011-00384
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    K081208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 3 OF 3. REFERENCE MFR REPORT #S 1627487-2011-00382 AND 1627487-2011-00383. THE PATIENT WAS RECEIVED AN SCS SYSTEM ON (B)(6) 2009 CONSISTING OF AN IPG, PERCUTANEOUS LEAD AND LEAD ANCHOR. IT WAS REPORTED THAT HER STIMULATION CHANGED FOLLOWING A RECENT FALL. DIAGNOSTIC TESTS REVEALED EITHER INVALID OR HIGH IMPEDANCE READINGS FOR SEVERAL LEAD CONTACTS. REPROGRAMMING WAS PERFORMED TO RECAPTURE ADEQUATE THERAPY COVERAGE; HOWEVER, THE PATIENT'S STIMULATION ISSUES REPORTEDLY PERSISTED. A SUBSEQUENT X-RAY REVEALED NO ISSUES WITH RESPECT TO LEAD POSITION, BUT IT WAS LATER DISCOVERED THAT THE LEAD HAD PARTIALLY PULLED OUT OF THE HEADER WITH THE ONE OF THE CONTACTS REMAINING IN THE IPG. THE PATIENT'S SCS SYSTEM WAS REPLACED AND EFFECTIVE STIMULATION WAS RECAPTURED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CINCH LEAD ANCHOR SPINAL CORD STIMULATION ANCHOR LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 1194 2844885

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention