BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2761063 · Received September 26, 2012

    Report

    Report Number
    3004209178-2012-08567
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    August 28, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) HAD REDUCED THERAPEUTIC EFFECT. THE PATIENT SYMPTOMS WERE PAIN, AND STIMULATION IN AN UNEXPECTED AREA. IT WAS ALSO REPORTED THAT THE INS WAS HEATING DURING RECHARGING. THE PATIENT HAD LOST 80 OR 40 POUNDS SINCE IMPLANT, 8 MONTHS AGO. THE INS WAS WORKING "WONDERFULLY" BEFORE THE INCIDENT. THE SYMPTOMS STARTED AROUND AUGUST 10, 2012, FOLLOWING "VIGOROUS SEXUAL ACTIVITY." HE WOKE UP "PUKING SICK" FROM EXTREME PAIN ON RIGHT THE SIDE, WHICH STARTED AT THE INS AND RAN TO THE ARM TO THE FINGER TIPS AND DOWN TO THE FOOT. THERE WAS PAIN IN HIS BACK AND LEGS AND HE STATED, "THAT HE CAN BARELY WALK BECAUSE OF THE PAIN IN HIS BACK." IT WAS STATED THAT HE, "TOOK OXYCONTINS LIKE TICTACS." AND WENT TO THE EMERGENCY ROOM. IN THE EMERGENCY ROOM, REPROGRAMMING HIS DEVICE WAS PARTIALLY SUCCESSFUL ON THE LEFT SIDE, FOR HIS LEGS, AND UNSUCCESSFUL ON THE RIGHT SIDE. IT WAS REPORTED THERE WAS NO STIMULATION SENSATION ON RIGHT SIDE OF THE BODY: LOWER BACK AND LEGS, AND NOT IN HIS BACK ON THE LEFT SIDE, BUT STIMULATION WAS FELT IN THE GROIN AND ABDOMEN. THE HCP TOOK "NUMEROUS X-RAYS," REVIEWED X-RAYS, NO ISSUE WAS SEEN, AND THE LOCATION OF THE LEAD LOOKED CORRECT. ANOTHER REPROGRAMMING SESSION WAS BEING PLANNED. IT WAS STATED THAT "HE THINKS THE PROBLEM MIGHT BE A BATTERY MALFUNCTION, AS HE, IS THE FOURTH PERSON IN THE COUNTRY TO RECEIVE THIS BATTERY." THERE WAS A WARM SENSATION IN OR AROUND THE INS POCKET DURING RECHARGING, AND THE SITE "HEATS UP LIKE A CELL PHONE." IT WAS STATED THAT THIS MAY HAVE BEEN PRESENT PRIOR TO THIS INCIDENT. IT WAS STATED THAT THE INS CANNOT BE CHARGED ALL THE WAY. IT WAS STATED THAT "IN ORDER TO FIND OUT WHAT IS WRONG, HE NEEDS SURGERY." THE PATIENT'S STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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