BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1202897 · Received October 17, 2008

    Report

    Report Number
    2182207-2008-06673
    Event Type
    Injury
    Date Received
    October 17, 2008
    Report Date
    September 19, 2008
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3998, LOT # LA1849, IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 7435, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7495LZ51, SERIAL # (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 7495LZ51, SERIAL # (B)(4), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD THE IPG AND MOST OF LEADS EXPLANTED FOR UNK REASONS. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) ¿STOPPED WORKING¿ IN 2005. IN ADDITION, THE LEADS WERE BROKEN. THE PATIENT NOTICED THE LEADS BROKE WHEN THE INS QUIT WORKING IN 2005. IT WAS NOT HELPING HIM. ACCORDING TO THE PATIENT, THE MANUFACTURER'S REPRESENTATIVE CONFIRMED THE INS WAS NOT WORKING ANY LONGER IN 2005. THE INS AND LEADS WERE TAKEN OUT IN 2005. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED FOR THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| MODEL LEADN LOT# UNK| EXPLANTED