BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3042467 · Received April 9, 2013

    Report

    Report Number
    3004209178-2013-04908
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 3778-60, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID: 3778-60, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID: 37746, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 37754, SERIAL#: (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    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

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS (B)(4) RESTORE, SERIAL # (B)(4)) FOUND NO ANOMALIES. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) STOPPED RECHARGING THREE MONTHS AFTER IMPLANT. IT WAS STATED BY THE PATIENT THEY COULD FEEL THE INS "TURN ON AND OFF" JUST FROM WALKING, SINCE IMPLANTED. IT WAS STATED THE MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT A WEEK PRIOR TO REPORT AND WAS ABLE TO GET 7-8 COUPLING BOXES BUT IT WAS "HARDER THAN USUAL". IT WAS THEN STATED THE PATIENT SUCCESSFULLY RECHARGED ONE TIME AFTER THIS AND WAS ABLE TO GET 8 COUPLING BOXES. ON THE DAY OF REPORT THE REPRESENTATIVE WAS GETTING A REPOSITION ANTENNA MESSAGE ON THE RECHARGER. IT WAS NOTED THE PATIENT WAS RECEIVING STIMULATION AT THIS TIME AND THE INS SHOWED ABOUT 25% CHARGED. IT WAS ALSO NOTED ANTENNA LOCATE FEATURE AND A PHYSICIAN MODE RESET (PMR) WERE UNSUCCESSFULLY PERFORMED. IMPEDANCES WERE CHECKED AND ALL WERE WITHIN NORMAL RANGE. AN X-RAY WAS PERFORMED AND IT WAS CONFIRMED THE INS WAS NOT FLIPPED BUT THE LEAD WAS "COMING OFF RIGHT SIDE". IT WAS LATER REPORTED ON (B)(4) 2013, ADDITIONAL PMR ATTEMPTS DID NOT WORK AND THE PATIENT WAS GOING TO BE SCHEDULED FOR AN INS REPLACEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) STOPPED RECHARGING. THERE WERE ZERO COUPLING BARS AND PREVIOUSLY THE INS GOT 8 OUT OF 8 COUPLING BARS. IT WAS CONFIRMED THAT THE INS WAS NOT FLIPPED. IT WAS STATED THAT THIS WAS NOT NORMAL BATTER DEPLETION. IT WAS NOTED THAT THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THAT THE DEVICE WAS EXPLANTED THE DAY BEFORE THE REPORT AND A NEW MODEL WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147214 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 00070 YR Required Intervention