BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4821381 · Received June 5, 2015

    Report

    Report Number
    3004209178-2015-10347
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Report Date
    May 28, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED:(B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE MANUFACTURER REPRESENTATIVE (REP) HAD NOT HAD A CHANCE TO MEET WITH THE PATIENT BUT WOULD DO, SO HOPEFULLY LATER THAT WEEK. THERE WAS NO TROUBLESHOOTING DONE AT THE TIME OF THE REPORT TO PROVIDE INSIGHT TO THE ISSUE. IT WAS UNKNOWN WHAT THE EVENT CAUSE WAS AND IF IT WAS DEVICE RELATED. THE PATIENT WAS RECEIVING THERAPY. THEN, IT WAS REPORTED THAT THE PATIENT¿S STIMULATION WAS WORKING JUST FINE. THE IMPEDANCE OF THE SYSTEM WAS FINE AND THE ONLY ISSUE WAS THE PATIENT HAD INADVERTENTLY TURNED THE ADAPTIVE STIMULATION OFF. THIS WAS CORRECTED AND THE PATIENT WAS VERY HAPPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S MAIN LEAD HADN¿T WORKED SINCE IMPLANT, DIDN¿T WORK LIKE IT WAS SUPPOSED TO, AND HAD DISCONNECTED, BURNT UP, OR BROKE SEVEN MONTHS AFTER IMPLANT. THE PATIENT DIDN¿T EVEN HAVE THE BATTERY SEVEN MONTHS AND THERE WAS AN ISSUE. THE LEAD WAS CHECKED IN AUGUST OF 2014 AND WASN¿T WORKING; THE PATIENT WASN¿T SURE WHEN THIS WOULD HAVE HAPPENED OR WHAT HAPPENED. SHE KEPT THE BATTERY CHARGED BUT WASN¿T SURE WHAT HAPPENED BUT IT DIDN¿T WORK LIKE IT WAS SUPPOSED TO. THE PATIENT ALSO REPORTED NEVER HAVING THERAPEUTIC EFFECT. THE PATIENT HAD THREE DIFFERENT SETTINGS AND USED ALL THREE OF THEM. THE PATIENT¿S HUSBAND HAD CANCER SO SHE HAD BEEN TIED UP WITH HIM AND HAD NOT BEEN BACK TO SEE THE PHYSICIAN WHO WASN¿T THERE ANYMORE AND NO LONGER HAD A DOCTOR BECAUSE OF HER INSURANCE. THE MANUFACTURER¿S REPRESENTATIVE (REP) FURTHER NOTED THEY WERE UNAWARE OF ANY DEVICE ISSUES WITH THIS PATIENT BUT HAD AN APPOINTMENT ON (B)(6) TO SEE THE PATIENT AT THEIR NEW PHYSICIAN¿S OFFICE. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECEIVED ASSISTANCE FROM HER DOCTOR AND/OR MANUFACTURER REPRESENTATIVE AND HER CONCERNS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365084 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1