BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3060176 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06321
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 28, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3586, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001. PRODUCT TYPE: LEAD: PRODUCT ID 7496, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED STIMULATION IN THE WRONG LOCATIONS AND THE "ELECTRODES WERE NOT WORKING." IT WAS ALSO STATED THE PATIENT HAD "TROUBLE WITH THE STIMULATION LOCATION EVER SINCE THE FIRST IMPLANTABLE NEUROSTIMULATOR (INS) WAS CHANGED" IN 2001. IT WAS ALSO NOTED THE PATIENT'S PAIN WAS WORSE WHEN SHE LAY DOWN AND HAD STOPPED USING THE INS. REPORTEDLY THE PATIENT HAD NOT HAD THE INS CHECKED OR HAD ANY PROGRAMMING ADJUSTMENTS SINCE "AROUND 2005-2006." IT WAS ALSO REPORTED THE INS "DIDN'T WORK", AND THE HEALTHCARE PROVIDER (HCP) DIDN'T "CHECK THE ELECTRODES ON THE SPINE, WHICH NEEDED TO BE REDONE." IT WAS STATED THE MANUFACTURER REPRESENTATIVE "CHECKED AND DISCOVERED THE LEADS WERE BROKEN" APPROXIMATELY SIX MONTHS AFTER THE IMPLANT WAS PLACED IN 2005. IT WAS ALSO STATED THE PATIENT COULD NOT GET STIMULATION FOR THE BOTTOM OF HER LEG; "IT USED TO WORK GREAT, NOW IT DIDN'T WORK AS WELL, LIKE IT SHOULD." THE PATIENT WAS REDIRECTED TO HER HEALTHCARE PROVIDER.

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PATIENT HAD HAD "6 HOURS OF SEIZURES".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS ALSO REPORTED THE PATIENT UNDERSTOOD THAT HER DEVICE WAS NOT WORKING ¿AS IT SHOULD,¿ BUT THE PATIENT DID NOT WANT TO BE SENT TO A NEUROSURGEON BECAUSE SHE WOULD NOT HAVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162315 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Other