BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4173961 · Received October 15, 2014

    Report

    Report Number
    3004209178-2014-19733
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    August 1, 2014
    Report Date
    December 22, 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
    AZ, 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

    PRODUCT ID 97754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 97740, SERIAL# (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2014 -(B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD FALLEN AND LANDED ON HIS BACK ¿ALMOST 2 MONTHS AGO.¿ IMMEDIATELY AFTER THE FALL, THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE WHOLE LEFT SIDE AND PART OF THE RIGHT SIDE WERE NOT WORKING. THE PATIENT COULD ONLY FEEL THERAPY IN A SMALL AREA IN THE LOWER BACK. AFTER BEING SEEN BY A MANUFACTURER REPRESENTATIVE ON (B)(6), IT WAS FOUND THAT ONE OF THE PATIENT¿S TWO PERCUTANEOUS LEADS WAS ¿COMPLETELY OUT OF IMPEDANCE¿ AND THE PATIENT HAD LOST COVERAGE ON THE RIGHT SIDE. AFTER IMAGING WAS DONE, THE LEADS WERE NOT FOUND TO HAVE VISIBLY MOVED. THE PATIENT WAS GOING TO BE SCHEDULED FOR A LEAD REVISION TO REPLACE THE LEAD. NO OUTCOME WAS 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 FROM THE CONSUMER REPORTED THEIR HEALTHCARE PROVIDER (HCP) WAS NO LONGER AT THEIR LOCATION, SO THEY WERE GIVEN THE ¿RUN AROUND FOR SO LONG¿ THAT BY THE TIME THE ISSUE WAS ADDRESSED THE CONSUMER¿S PRE-EXISTING HEART CONDITION CAUSED THEIR HEART CONDITION TO DETERIORATE SO THEY WERE NO LONGER ELIGIBLE TO BE CLEARED FOR SURGERY BY THEIR PRIMARY CARE PHYSICIAN (PCP), SO A REVISION WASN¿T POSSIBLE. THE CONSUMER STATED THEY HADN¿T USED THE DEVICE SINCE THE FALL AND SUDDENLY ONLY FEELING STIMULATION ON THE RIGHT SIDE, BUT THEY WANTED TO SEE IF THEY COULD GET IT WORKING. IT WAS NOTED THE CONSUMER DIDN¿T MENTION THE DEVICE WAS OVERDISCHARGED OR WAS UNABLE TO BE COMMUNICATED WITH BUT BASED ON THE TIMEFRAME AND DEVICE CAPABILITY PATIENT SERVICES REVIEWED THEY WERE SURE OVERDISCHARGE WAS LIKELY TO HAVE OCCURRED BY NOW.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NOT YET BEEN SCHEDULED FOR THE LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655973 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention