BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3901884 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12259
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND THE ¿INS WAS RECEIVED IN AN UNOPENED SHRINK-WRAPPED BOX AND HAD EXPERIENCED A PARITY POR. ACCORDING TO THE DIAGNOSTIC DATA TAKEN FROM THE INS, THE PARITY POR COUNT WAS AT 3. THIS INDICATES THAT A RECHARGER AND/OR PROGRAMMER HAD COMMUNICATED WITH THE INS 3 TIMES AFTER A PARITY POR HAD OCCURRED AND PRIOR TO IT BEING CLEARED. THE FIRMWARE IN THE INS WAS DESIGNED SO THAT IF A PARITY ERROR IS RECORDED IN THE LOG, THEN A POR WOULD TAKE PLACE AND THE CUSTOMER WOULD BE INFORMED VIA THE PHYSICIAN PROGRAMMER, PATIENT PROGRAMMER, OR RECHARGER. UNTIL THE PARITY POR IS CLEARED, THE FIRMWARE IN THE INS ASSUMES ANOTHER PARITY POR HAS OCCURRED AND WILL CONTINUALLY INFORM THE CUSTOMER THAT A POR HAS OCCURRED. THIS ISSUE WILL OCCUR WHENEVER A PARITY POR IS THE LAST POR LOGGED IN THE INS. THE INS PASSED FUNCTIONAL TESTING.¿

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A RECHARGER COMMUNICATED WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) PRIOR TO IMPLANT THAT A POWER ON RESET (POR) MESSAGE APPEARED. IT WAS STATED THIS HAD OCCURRED WHEN THE REPORTER WAS ATTEMPTING TO PRE-CHARGE THE INS. IT WAS NOTED, THE INS WAS NOT IMPLANTED AT THE TIME OF REPORT DUE TO THE PRESENCE OF THE POR MESSAGE. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380291 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1