BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3072967 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06760
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 9, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 74002. PRODUCT TYPE: ADAPTER: PRODUCT ID 3998, LOT# L92553, IMPLANTED: (B)(6) 2002. PRODUCT TYPE: LEAD: PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002. PRODUCT TYPE: EXTENSION: PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002. PRODUCT TYPE: EXTENSION: PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS "DEAD". IT WAS STATED THAT A REPLACEMENT SURGERY WAS SCHEDULED FOR (B)(6) 2013. ONE WEEK LATER IT WAS REPORTED THAT THE PATIENT'S ENTIRE SYSTEM REMOVED AND REPLACED WITH A NEW MODEL. IT WAS STATED THAT THE ORIGINAL REASON FOR SURGERY WAS BECAUSE THE INS WAS IN AN UNCOMFORTABLE LOCATION AND IT NEEDED TO BE REVISED. FURTHER INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN IN THE TAILBONE WHERE THE OLD STIMULATOR USED TO BE. IT WAS NOTED THAT THE PATIENT HAD ¿MASSIVE PAIN.¿ IT WAS NOTED THAT THE PAIN STARTED OVER THE LAST FEW WEEK AND IT HAD LIMITED THE PATIENT¿S WALKING. IT WAS NOTED THAT THE PAIN FELT LIKE WHEN YOUR FOOT FALLS ASLEEP AND IT BURNED. IT WAS NOTED THAT THE PAIN WAS IN THE LOCATION OF WHERE THE OLD IMPLANT USED TO BE. IT WAS NOTED THAT THE PAIN WAS ¿OFF TO THE RIGHT SIDE.¿ IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE WAS IN THE ROOM WHEN THE EXPLANT WAS PERFORMED AND SAID THAT THERE WAS NOTHING WRONG. IT WAS NOTED THAT THE LEADS WERE ALSO REPLACED. IT WAS NOTED THAT THE PATIENT WAS ¿EATING PILLS LIKE CRAZY¿ TO HELP WITH THE PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THERE WOULD BE NO PRODUCT RETURNS. IT WAS STATED THAT PATIENT'S THERAPY WAS EFFECTIVE AND THE OUTCOME WAS GOOD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S TAILBONE WAS ALWAYS NUMB AND TINGLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175317 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention