BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2891252 · Received December 31, 2012

    Report

    Report Number
    3004209178-2012-12399
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    December 7, 2012
    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

    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).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND THAT THE PARITY POWER ON RESET (POR) BIT WAS NOT RESET. IT WAS STATED THE INS WAS RECEIVED IN AN UNOPENED SHRINK-WRAPPED BOX. THE INS HAD EXPERIENCED A PARITY POR. THE PARITY COUNT WAS AT 2, ACCORDING TO THE TRACE REPORT. THIS INDICATED THAT A RECHARGER AND/OR PROGRAMMER HAD COMMUNICATED WITH THE INS TWICE AFTER A PARITY POR HAD OCCURRED AND PRIOR TO IT BEING CLEARED. IT WAS NOTED THAT UNTIL THE POR WAS CLEARED, THE FIRMWARE IN THE INS WOULD ASSUME ANOTHER PARITY POR OCCURRED AND WOULD CONTINUALLY INFORM THE CUSTOMER THAT A POR HAD OCCURRED. IT WAS NOTED THIS ISSUE WOULD OCCUR WHENEVER A PARITY POR WAS THE LAST POR LOGGED IN THE INS. IT WAS FURTHER STATED THE INS PASSED FUNCTIONAL TESTING AND RECHARGED NORMALLY.

    Description of Event or Problem · 1

    THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A POWER ON RESET (POR) CONDITION. IT WAS NOTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WOULD BE EXPIRING ON (B)(6) 2012. IT WAS NOTED THEY ATTEMPTED TO RECHARGE INS AND HAD DIFFICULTY BUT ON THE THIRD ATTEMPT IT WAS ABLE TO CHARGE AND DISPLAY A POR MESSAGE ON THE INS RECHARGER. UPON INTERROGATION OF THE INS A POR WAS SEEN WITH A CIRCLE AND "X" ICON. THEY WERE ABLE TO BYPASS POR MESSAGE ONCE WITHOUT HAVING TO REPEAT THE PROCESS. IT WAS NOTED THEY APPLIED THE INS RECHARGER AND HAD DIFFICULTY BUT WAS ABLE TO COMMUNICATE ON THE SECOND ATTEMPT. IT WAS NOTED THE REPORTER DID NOT FEEL COMFORTABLE USING THE INS. FOLLOW UP REPORTED THERE WAS NO PATIENT INVOLVEMENT. THE REPRESENTATIVE WANTED TO CHARGE THE INS UP THROUGH THE BOX PRIOR TO IMPLANTING AND THAT WAS WHEN THEY RECEIVED THE POR MESSAGE. THERE WAS NO CODE ASSOCIATED WITH THE POR. TECHNICAL SERVICES SAID THIS WAS A KNOWN ISSUE WITH THE SENSOR MODEL INS AND THAT IT WOULD BE OKAY TO IMPLANT THE DEVICE. REPRESENTATIVE DID NOT WANT TO USE THE DEVICE FOR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1