BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3191326 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10929
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    February 20, 2007
    Report Date
    June 21, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3998, LOT# V013615. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS NOT IMPLANTED WITH A NEW SYSTEM. THERE WAS NO TROUBLESHOOTING DONE WITH THE OLD SYSTEM. IT WAS STATED THAT THE PATIENT WAS NOW IN PAIN.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED NERVE DAMAGE AFTER RECEIVING THEIR IMPLANTABLE NEUROSTIMULATOR (INS), THOUGH IT WAS NEVER STATED THAT THE INS WAS THE CAUSE OF THE NERVE DAMAGE. THE PATIENT STATED THAT THE INS HELPS WITH HER PAIN, BUT SHE CAN ONLY HAVE IT ON FOR 5-10 MINUTES DUE TO BURNING PAIN SHE GOT DOWN HER LEGS. A COMPANY REPRESENTATIVE ATTEMPTED TO REPROGRAM THE PATIENT, BUT IT DID NOT RESOLVE THE ISSUE. THE PATIENT ALSO REPORTED AN OVERSTIMULATION SENSATION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN THAT REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) ¿DOES NOT WORK.¿ THE DOCTOR REPORTED THE INS WAS GOING TO BE EXPLANTED BECAUSE ¿IT IS A PROBLEM WHERE IT IS IMPLANTED.¿ NO IMPEDANCE MEASUREMENTS WERE TAKEN. IT WAS ALSO REPORTED THAT THE LEADS WERE IN THE WRONG PLACE AND THE DOCTOR WAS UNABLE TO PROGRAM THE INS PROPERLY. EXPLANT OF THE INS WAS SCHEDULED FOR (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290873 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention