BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2950559 · Received February 8, 2013

    Report

    Report Number
    6000032-2013-00034
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENSION. PRODUCT ID 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENSION. PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3487DBQ, LOT# N24381, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT A YEAR PRIOR TO THE REPORT, THE PATIENT WAS HAVING "PROBLEMS" WITH THE LEADS. THE PATIENT SAW A HEALTHCARE PROVIDER (HCP) IN (B)(6) 2012 WHO STATED THAT THE LEADS COULD EITHER BE REMOVED, WHICH COULD BE WORSE, OR MOVED UP. HOWEVER, THE LATTER OPTION WOULD HAVE CAUSED THE LEADS TO BE NEAR WHERE THE PATIENT'S PAIN WAS. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55033 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1