BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 5694585 · Received June 2, 2016

    Report

    Report Number
    3004209178-2016-10734
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Date of Event
    May 16, 2016
    Report Date
    June 15, 2016
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THERE WAS AN ADAPTIVE STIMULATION ISSUE WHERE THE TRANSITION TIME SEEMED INCORRECT. SINCE ORIENTING THE IMPLANTABLE NEUROSTIMULATOR (INS), WHEN THE PATIENT WAS IN BED AT NIGHT AND THEY TURN OVER, THE DEVICE GOES TO UPRIGHT AND SHOCKS THEM. IT WAS REPORTED THAT THE REP WOULD MEET WITH THE PATIENT AND ADJUST THE ADAPTIVE STIMULATION SETTINGS. THEY WOULD ALSO CHECK TO SEE IF THE INS WAS MOVING IN THE POCKET. THERE WAS A REPORT OF A SUDDEN SHOCKING AT THE THERAPY SITE WHENEVER THE PATIENT TURNS OVER IN BED. RELEVANT MEDICAL HISTORY INCLUDES CHRONIC LOW BACK PAIN, LUMBAR RADICULOPATHY, AND SPINAL PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTING THAT THE ISSUE DID NOT HAPPEN EVERY NIGHT. IT WAS RANDOM. THE ISSUE CONTINUED TO OCCUR. WHEN THE PATIENT RECLINED THE AMPLITUDE WOULD NOT DECREASE ALL THE WAY LIKE IT SHOULD. THE PATIENT WOULD LIKE LYING AMPLITUDE WHEN THEY WERE RECLINING. THE MANUFACTURER REPRESENTATIVE HAD NOT ORIENTED THE INS SINCE THE PREVIOUS CALL. AFTER THE LAST CALL, THE TRANSITIONS WERE ADJUSTED TO THE FOLLOWING SETTINGS: UPRIGHT TO LYING-0 SEC, LYING TO UPRIGHT-20 SEC, UPRIGHT TO MOBILE-2 MIN, MOBILE TO UPRIGHT-2 MIN, AND LYING TO LYING-0 SEC. THE MOBILITY RATE WAS MID-RANGE. THE CURRENT POSITION RANGE WAS SET TO XXS FOR UPRIGHT AND SMALL FOR LYING. DURING TROUBLESHOOTING, THE MANUFACTURER REPRESENTATIVE CHANGED THE UPRIGHT TO MEDIUM AND THE LYING TO XL. THE POSITION WAS TESTED WHEN THE PATIENT WAS SITTING UP IN A CHAIR AND IT WAS SHOWING THE INS WAS IN TRANSITION RANGE. THE UPRIGHT WAS CHANGED TO LARGE AND TESTED THE POSITION AGAIN, WHICH SHOWED UPRIGHT. THE PATIENT DID NOT HAVE ANY RECHARGING ISSUES. THERE WERE NO PATIENT SYMPTOMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349424 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR