BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3213177 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11486
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE DEVICE, MODEL 7427, SERIAL NO. (B)(4), FOUND NO SIGNIFICANT ANOMALIES AND FUNCTIONALLY OKAY. ANALYSIS OF THE EXTENSION, MODEL 748925, SERIAL NO. (B)(4), FOUND NO SIGNIFICANT ANOMALIES AND FUNCTIONALLY OKAY. ANALYSIS OF THE EXTENSION, MODEL 748925, SERIAL NO. (B)(4), FOUND NO SIGNIFICANT ANOMALIES, BODY CUT THROUGH, PRODUCT SEGMENTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION; PRODUCT ID 3998, LOT# J0428216V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD; PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD GRADUAL LOSS OF CONTACTS DUE TO HIGH IMPEDANCES. IT WAS NOTED THE PATIENT HAD REPROGRAMMING PERFORMED ON (B)(6) 2009. IT WAS REPORTED THE REPROGRAMMING COULD NOT ACHIEVE PARESTHESIA COVERAGE. IT WAS NOTED THE PATIENT OUTCOME WAS NO INJURY. IT WAS REPORTED THE EXPLANT OF THE LEAD WAS DUE TO THE HIGH IMPEDANCES. IT WAS NOTED THE PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S ENTIRE SYSTEM WAS EXPLANTED BECAUSE THE PATIENT WAS NOT USING THE SYSTEM AND THE PATIENT REQUIRED AN MRI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND NOT REPLACED. IT WAS NOTED THAT A SPINAL CORD STIMULATION (SCS) FAILURE HAD OCCURRED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EXPLANT WAS PERFORMED ON (B)(6) 2013. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE PATIENT WAS HAVING ISSUES WITH THE WIRING AND PADDLES PRIOR TO EXPLANT. THE DEVICE WAS BROKEN. HE WOULD LIKE A NEW DEVICE SYSTEM IMPLANTED AND WAS LOOKING FOR A NEW PHYSICIAN TO DO THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312558 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention