BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2931934 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01063
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 12, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-56, LOT # V173876, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3487A-56, LOT # V181340, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION WHEN THE STIMULATOR WAS FIRST TURNED ON AFTER HAVE THE IM PLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT SURGERY. IT WAS STATED THAT THE PATIENT "FELL TO THE FLOOR BECAUSE AS SOON AS HE PRESSED THE ON BUTTON, HE GOT SUCH A STRONG SHOCK, HE COULD NOT EVEN MOVE." THE PATIENT FELT AS THOUGH HE HAD BEEN TAZED. THE PATIENT STATED THAT HE HAD NEVER HAD THIS PROBLEM BEFORE. IT WAS STATED THAT THEY "DID A FEW PROGRAMS AT THE HOSPITAL." THE PATIENT WAS VERY ANGRY. THE PATIENT STATED THAT THE DEVICE "BASICALLY PARALYZED" HIM AND HE WAS "HARDLY ABLE TO TAKE A BREATH." THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013 TO MEET WITH HIS DOCTOR. IT WAS STATED THAT IT "TOOK A WHILE FOR THE PATIENT TO BE ABLE TO TURN STIMULATION OFF." NO FURTHER INFORMATION ABOUT THIS EVENT WAS REPORTED. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37424 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 Disability