BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3172771 · Received June 17, 2013

    Report

    Report Number
    6000032-2013-00154
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3487A-45, LOT # J0349101V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 7435, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-45, LOT # J0349101V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 8840, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN . (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A POWER-ON-RESET (POR) CONDITION. IT WAS REPORTED THERE WAS A LOSS OF STIMULATION 3 WEEKS PRIOR AND THE CLINICIAN PROGRAMMER WAS SHOWING A POR THE DAY OF REPORT. THE REPORTER INTERROGATED THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THEN LATER TRIED TO REINTERROGATE THE INS WITH A CLINICIAN PROGRAMMER BUT THERE WAS NO TELEMETRY FROM THE INS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE CAUSE OF THE EVENT WAS NORMAL DEP LETION (END OF LIFE) OF THE IMPLANTABLE NEUROSTIMULATOR (INS). THE INS WAS EXPLANTED AND REPLACED WITH A NEW DEVICE ON (B)(6), 2013. HOSPITALIZATION WAS NOT REQUIRED FOR THE EVENT. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ERROR CODE THAT ACCOMPANIED THE POR WAS UNKNOWN. IT WAS NOTED THAT THE BATTERY WAS DEPLETED AND NEEDED TO BE REPLACED. IT WAS NOTED THAT THE PATIENT OUTCOME AT THE TIME OF REPORT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274200 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR