BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3935540 · Received July 15, 2014

    Report

    Report Number
    3004209178-2014-13029
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 9 7754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NEVER HAD THERAPEUTIC EFFECT. THE PATIENT HAD TO GO IN EVERY WEEK TO HAVE THEIR STIMULATION ADJUSTED. IT WAS FURTHER REPORTED THAT IT WAS UNKNOWN IF THERE WAS A >50% SYMPTOM REDUCTION. THE CAUSE OF THE EVENT WAS DETERMINED TO BE THAT THE ELECTRODES MOVED CEPHALAD WHICH CAUSED ANTERIOR STIMULATION. ATTEMPTS AT REPROGRAMMING WERE UNSUCCESSFUL. ANTERIOR-POSTERIOR FILMS WERE TAKEN AT THE DOCTOR¿S OFFICE. THE PATIENT OUTCOME WAS LISTED AS RECOVERED WITHOUT PERMANENT IMPAIRMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412119 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1