BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3122741 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07996
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    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

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 37714 SERIAL # (B)(4), SHOWED A DEFORMED #1 BALSEAL. A KNOWN GOOD LEAD COULD NOT BE INSERTED PAST THE #1 BALSEAL CONNECTOR AND #1 BALSEAL SPRING APPEARED DEFORMED ON X-RAY. IT WAS NOTED THAT A KNOWN GOOD LEAD COULD BE INSERTED INTO THE #8-15 CONNECTOR PORT. NO ELECTRICAL TESTING WAS SINCE THE DEVICE WAS NOT USED FUNCTIONALLY IN THE FIELD AND THAT THE COMPLAINT WAS RELATED TO A LEAD INSERTION ISSUE (THIS ALSO PRESERVED THE ORIGINAL CONDITION OF THE #1 BALSEAL SPRING).

    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 DURING THE IMPLANTATION OF THE IMPLANTABLE NEUROSTIMULATOR (INS), THE LEAD COMPONENT COULD NOT BE INSERTED INTO THE TOP CHANNEL OF THE HEADER BLOCK (FOR ELECTRODES #0 TO 7). THE SETSCREW WAS BACKED OUT SOME BUT THE LEAD STILL WOULD NOT GO IN THE CHANNEL. IT WAS ALSO ATTEMPTED TO SLIGHTLY ROTATED THE LEAD DURING INSERTION BUT THIS WAS UNSUCCESSFUL. NOTHING ON THE LEAD WAS PRESENT, VISUALLY, THAT WOULD STOP IT FROM BEING INSERTED INTO THE CHANNEL. IT WAS REPORTED THAT THE LEAD COULD BE INSERTED INTO THE LOWER CHANNEL OF THE HEADER BLOCK (FOR ELECTRODES #8 TO 15) WITH NO ISSUES. A NEW INS WAS THEN USED WHICH RESOLVED THE LEAD INSERTION ISSUE. ADDITIONAL INFORMATION RECEIVED 8 DAYS LATER CLARIFIED THAT THE LEAD WOULD ADVANCE AS FAR AS THE FIRST 2 TO 3 ELECTRODES BUT NO FURTHER. USING A WRENCH IN THE 0 TO 7 CHANNEL DID NOT HELP. IT WAS CONFIRMED THAT THE INS NEVER USED IN THE PATIENT. NO PATIENT INJURIES WERE REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224909 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 00066 YR