BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3869701 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-11479
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THE PATIENT WAS REPROGRAMMED THIS PAST WEDNESDAY. SINCE THE REPROGRAMMING, THE STIMULATION HAS BEEN TURNING ON/OFF BY ITSELF. THE ADAPTIVE STIM (AS) WAS ALL RESET TO A DIFFERENT SETTING. THE AS DID NOT RECOGNIZED THE NEW SETTING, HAS GONE BACK TO OLD SETTING, EVEN AFTER THE 3 MINUTE TIMER. WHEN THE PATIENT WAS LYING ON HER BACK, SHE DECREASED HER STIMULATION TO 0V, SET HER PHONE TIMER TO 3 MINUTES, RAISED AND BENT HER LEG. AFTER THE 3 MINUTES, THE DEVICE WENT UP TO 1.70V AND IT WAS DISPLAYING LYING ON HER BACK. AT THAT TIME THE PATIENT FELT JOLTING FROM HER STIMULATION. THE INS WAS NOT RECOGNIZING THE LAST SETTING SHE PROGRAMMED WITH HER PATIENT PROGRAMMER. THE ONLY POSITION THE INS DISPLAYED WAS LYING ON HER BACK, NO MATTER WHAT POSITION THE PATIENT WAS IN. THE INS POCKET DID NOT SEEM LOOSE NOR DID IT SEEM LIKE THE DEVICE WAS MOVING AROUND. THE COMPANY REPRESENTATIVE PALPATED THE INS POCKET AND IT DID NOT SEEM LOOSE TO HIM. THE PHYSICIAN PROGRAMMER (8840) DISPLAYED THE FOLLOWING: LYING ON BACK WHEN IN A SITTING POSITION, LYING ON BACK WHEN LYING ON RIGHT SIDE, LYING ON BACK WHEN LYING ON BACK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT¿S DEVICE WAS REORIENTED AND THE SHOCKING SENSATION WAS ELIMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347413 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR