BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3031535 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04513
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 14, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID 377760 LOT# V009505, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 377760 LOT# V009505, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    SUPPLEMENTAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S HCP (HEALTH CARE PROVIDER) DID NOT KNOW THE CAUSE OF THE EVENT, BUT A THORACIC X-RAY WAS GOING TO BE PERFORMED TO CHECK THE LEAD PLACEMENT. IT WAS NOTED THAT THE PATIENT WAS REPROGRAMMED LAST WEEK AND THE AREA WAS COVERED; HOWEVER, WHEN THE PATIENT TURNED IT UP ENOUGH TO PROVIDE RELIEF, THE SENSATION WAS PAINFUL AND HAD TO BE TURNED DOWN. IT WAS INDICATED THAT THE MANUFACTURER REPRESENTATIVE MENTIONED A LEAD WAS NOT WORKING. THE PATIENT¿S OUTCOME WAS REPORTED AS NO INJURY. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FEELING STIMULATION IN THE WRONG LOCATION AND THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT REACHING THE "CORRECT SPOT". IT HAD BEEN A WHILE SINCE THE PATIENT USED THE INS BECAUSE, THE PATIENT DIDN'T HAVE TIME AND THE DEGREE OF PAIN THE PATIENT WAS HAVING REQUIRED A LOT OF NARCOTICS. THE REPORTER NOTED THAT THE PATIENT HAD STARTED USING THE INS AGAIN AND SHE NEEDED THE INS MORE NOW. THE REPORTER INDICATED THAT SOMETIMES, THE PATIENT GOT SHOCKED. THE REPORTER ALSO STATED THAT THE PATIENT HAD A LEAD REPLACED, SOMETIME IN 2011. THERE WAS HOWEVER NO INDICATION THAT THIS WAS RELATED TO THE PATIENT'S SHOCKING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133807 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1