BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2924698 · Received January 22, 2013

    Report

    Report Number
    6000032-2013-00017
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 2, 2013
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003. PRODUCT TYPE: EXTENSION: PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003. PRODUCT TYPE: EXTENSION: PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3998, LOT# J0406043V, IMPLANTED: (B)(6) 2004. PRODUCT TYPE: LEAD: PRODUCT ID 3998, LOT# LB6920, IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2004. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN AT END OF LIFE SINCE (B)(6) 2012. IT WAS STATED THE STIMULATION NEVER WORKED FOR THE PATIENT'S LOWER BACK. THE TRIAL "WORKED FINE" FOR THE PATIENT, BUT THE INS DID NOT. IT WAS STATED A LEAD WAS RE-IMPLANTED, BUT "IT STILL DID NOT STIMULATE ABOVE THE HIPS." IT WAS STATED THE PATIENT HAD THE PROCEDURE TWICE, BUT IT "NEVER HELPED" THE PATIENT'S BACK PAIN. IT WAS UNCLEAR IF THE LEAD PROCEDURES OCCURRED BEFORE THE INS REACHED END OF LIFE. IT WAS NOTED THE PATIENT WAS "IN THE PROCESS" OF REPLACING THE INS. IT WAS STATED BY THE PATIENT THAT THE HEALTHCARE PROVIDER WAS TO REPLACE THE INS DUE TO LUMBAR DEGENERATIVE DISC DISEASE. IT WAS INDICATED BY THE PATIENT THAT THE INS "DOES NOT WORK" AND IT HAD "FAILED TWICE." IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31217 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention