BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2862603 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11302
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 12, 2012
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377860, LOT # V020196, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 377860, LOT # V020196, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A "SHOCKING OR JOLTING" SENSATION. THE PATIENT HAD TO TURN OFF HER STIMULATION AND IT WAS STILL OFF AT THE TIME OF THE REPORT BECAUSE OF THE "ELECTRICAL JOLTS." THE PATIENT STATED SHE WAS GETTING SHOCKED IN HER "VERY PERSONAL AREA." THE PATIENT STATED IT WAS NOT A "PICNIC" BEING WITHOUT THE DEVICE, BUT GETTING SHOCKED WAS WORSE. THE PATIENT ALSO MENTIONED AN X-RAY WAS TAKEN AND IT SHOWED HER DEVICE HAD "TURNED" AND "MOVED ALL OVER" AND THE POCKET WAS "TOO LARGE." THE PATIENT STATED SHE TOOK ONE AND A HALF YEARS TO HEAL AND SHE WAS A "QUICK HEALER." ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD PAIN FROM THE SYSTEM ¿WAY LONGER THAN SHE EXPECTED TO.¿ THE PATIENT WAS IN PAIN FOR ¿ALMOST TWO YEARS¿ AFTER IMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1