BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 3223859 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11681
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 18, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3093-28, LOT# V013943, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3093-28, LOT# V013728, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A REVISION SURGERY. THE PATIENT RECEIVED A NEW EXTENSION AND INS DUE TO "PATIENT WASN'T GETTING SYMPTOMS RELIEF". SEE MANUFACTURER'S REPORT # 3007566237-2013-02328 FOR ISSUES THAT OCCURRED INTRAOPERATIVELY FOLLOWING THE REVISION SURGERY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS HIGH IMPEDANCE AND THE EVENT WAS ATTRIBUTED TO THE LEAD. IT WAS NOTED THAT THE LEFT LEAD HAD HIGH IMPEDANCE GREATER THAN 4000 OHMS. IT WAS UNKNOWN WHAT THE ISSUE WAS AND THE IMPLANTABLE NEUROSTIMULATOR WAS REPLACED ON 2013-(B)(6). IT WAS NOTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THERE WAS NO INJURY TO THE PATIENT. IT WAS UNCLEAR IF THE PATIENT REQUIRED HOSPITALIZATION OR NOT, AS IT WAS PREVIOUSLY REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323302 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R