BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 4013039 · Received August 15, 2014

    Report

    Report Number
    6000032-2014-00163
    Event Type
    Injury
    Date Received
    August 15, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3998, LOT # LA5495, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 7435, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE PROGRAMMER, PATIENT; 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 3998, LOT # LA5495, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2005 THE PATIENT SAW A HEALTHCARE PROFESSIONAL (HCP) WHO INDICATED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PLACED IN THE INCORRECT POSITION. THE INS WAS TAKEN OUT, BUT WHEN THE HCP ¿PULLED ON THE WIRES¿ THEY WOULD NOT PULL FREE. THE PATIENT CURRENTLY HAD ONLY THE WIRES IMPLANTED. THE DATE OF THE INS EXPLANT AND OUTCOME WERE NOT REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN 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
    490040 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention