BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3268008 · Received August 7, 2013

    Report

    Report Number
    3004209178-2013-12879
    Event Type
    Malfunction
    Date Received
    August 7, 2013
    Report Date
    July 10, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3550-29 LOT# N142754, IMPLANTED: 2008 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    AWARE DATE UPDATED AFTER CLARIFICATION FROM REPRESENTATIVE. THE ORIGINAL REPORT WAS INCORRECTLY MARKED AS LATE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ELECTROCUTED WHILE WORKING ON HIS CAR TWO DAYS PRIOR TO THIS REPORT. IT WAS NOTED THAT THE PATIENT ALSO REFERRED TO THIS INCIDENT AS ¿WHEN HE GOT SHOCKED.¿ THE PATIENT STATED THAT SINCE HE HAD BEEN ELECTROCUTED, HE HAD A BURNING SENSATION THAT WENT UP HIS SPINE. THE PATIENT STATED THAT HIS IMPLANTABLE NEUROSTIMULATOR (INS) HAD NOT WORKED FOR THE PAST YEAR. THE PATIENT STATED THAT HE COULD NOT EVEN GET IT TO ¿CUT ON.¿ THE PATIENT REPORTED THAT HE HAD FALLEN SEVERAL TIMES WITHIN THE PAST YEAR AND HE HAD FALLEN TWICE ON THE DAY PRIOR TO THIS REPORT AND HAD LANDED DIRECTLY ON THE INS. THE PATIENT STATED THAT HAD ALSO FALLEN AND ¿FLEW BACK¿ ABOUT FIVE FEET WHEN HE WAS ELECTROCUTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE CLARIFIED THAT HE WAS FIRST MADE AWARE OF THE PATIENT BEING ELECTROCUTED ON (B)(6) 2013. THE PATIENT¿S DEVICE WAS REPLACED AND IT WAS IN AN OVERDISCHARGED STATE. LATER THAT DAY IT WAS REPORTED THAT THE REASON THE DEVICE WAS OVERDISCHARGED WAS PATIENT COMPLIANCE AS HE DID NOT CHARGE HIS DEVICE. THEY TRIED TO ¿TRIPLE CHARGE¿ BUT WERE UNSUCCESSFUL. THE BATTERY WAS REPLACED ON (B)(6) 2013 AND THE PATIENT WAS DOING VERY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371157 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention