BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2973719 · Received February 22, 2013

    Report

    Report Number
    3007566237-2013-00568
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    January 29, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTS (VIA SOCIAL MEDIA) THAT FOR THE PAST 7 WEEKS THEY HAVE NOT BEEN GETTING MEDICATION FROM THE PUMP FOR DAYS AT A TIME AND THEN ALL OF A SUDDEN THE PUMP STARTS WORKING AGAIN. ALL OF THE PATIENT'S PAIN WAS BACK AND THE PATIENT WAS HAVING WITHDRAWAL. THE PATIENT'S DOCTOR RAN A PUMP TEST WHICH SHOWED NO PROBLEMS. A CT SCAN ON THE PUMP TUBING WAS DONE AND SHOWED NO PROBLEMS. THE PUMP PRINT-OUT WAS NOT SHOWING ANY "BATTERY SURGES RELATED TO RECALL." THE PATIENT MADE AN APPOINTMENT TO SEE A NEW PHYSICIAN ABOUT THE PUMP. THE NEW PHYSICIAN SAID THE CT SCAN WOULD NOT SHOW A PROBLEM WITH THE PUMP AND THAT A DYE TEST WOULD HAVE TO BE DONE. THE PATIENT WAS TOLD BY HIS PRIOR PHYSICIAN THAT A DYE TEST COULD NOT BE DONE ON THE PUMP. THE PATIENT SAW THEIR ORIGINAL PHYSICIAN AGAIN AND "STILL NO PROGRESS." THE PATIENT STATES HAVE "BEEN SUFFERING FOR 2 MONTHS NOW, WITH NO HELP." THE PHYSICIAN TOLD THE PATIENT HE COULD NOT REPLACE THE PUMP. THE PATIENT'S PUMP HAD "FAILED 2 TIMES BEFORE" (SEE MANUFACTURER'S REPORT NUMBERS 3007566237-2013-00566 AND 3007566237-2013-00567 FOR THE PATIENT'S 2 PRIOR PUMP FAILURES). THE PATIENT'S "BIGGEST WORRY" WAS THAT "THE NEXT TIME, LUCK WILL NOT BE ON MY SIDE." THE COMPLAINT CAME IN VIA SOCIAL MEDIA; NO FOLLOW-UP IS POSSIBLE AT THIS TIME DUE TO LACK OF CONTACT INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78682 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1