BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 6380548 · Received March 6, 2017

    Report

    Report Number
    3004209178-2017-05072
    Event Type
    Injury
    Date Received
    March 6, 2017
    Date of Event
    January 23, 2017
    Report Date
    March 6, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF OVERDISCHARGE EVENT WAS REPORTED AS "5 WEEKS AGO" (JAN. 2017). 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A CONSUMER IMPLANTED FOR SPINAL PAIN REPORTED VIA THE MANUFACTURER¿S REPRESENTATIVE (REP) THEY HADN¿T RECHARGED SINCE (B)(6) 2016. IN (B)(6) 2017 THE CONSUMER REALIZED THEY WERE UNABLE TO COMMUNICATE WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) AND IT WAS OVERDISCHARGED. ON (B)(6) THE REPRESENTATIVE MET WITH THE CONSUMER AND PERFORMED A PHYSICIAN MODE RECHARGE (PMR), WHICH WAS THE 5TH THE CONSUMER TRIED, BUT AFTER ONE 60 MINUTE SESSION WAS COMPLETED THE RECHARGER DISPLAYED THE NUMBER ¿2936037.¿ THE REPRESENTATIVE INITIALLY STATED THE RECHARGER WAS ONLY DISPLAYING THIS NUMBER BUT AFTER FURTHER TROUBLESHOOTING WAS PERFORMED THE RECHARGER THEN DISPLAYED THE NORMAL REPOSITION ANTENNA SCREEN. AN ATTEMPT WAS THEN MADE TO PULL THE RECHARGING STATISTICS BUT THE LAST DATE IT SHOWED WAS (B)(6) 2000 SO THE INS DATE WAS RESET BEFORE THE LAST RECHARGING SESSION. IT WAS THEN RECOMMENDED TO THE REPRESENTATIVE TO USE THE ANTENNA LOCATE FEATURE WHICH RESULTED IN RANGE OF 56-70. THE REP. THEN ATTEMPTED TO MOVE THE RECHARGING ANTENNA BUT THERE WAS AN ADHESIVE PATCH APPLIED AND DURING THE ATTEMPT TO MOVE IT THE CONSUMER CLAIMED IT HURT WHEN THEY UNSTUCK THE DISC. FOLLOW UP INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE ON (B)(6) 2017 REPORTED THAT AS TROUBLESHOOTING FOR THE POOR COMMUNICATION, THE BATTERY WAS REPOSITIONED AND TESTED AGAIN. THE BEST NUMBERS THE REPRESENTATIVE WAS ABLE TO GET WAS 57 AND 70. THE REPRESENTATIVE TRIED 4 RECHARGES BUT THEY WERE UNSUCCESSFUL. THE PATIENT WILL REQUEST THE INS BATTERY BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164391 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention