BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3071832 · Received April 22, 2013

    Report

    Report Number
    6000032-2013-00101
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    April 8, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7495-51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE EXTENSION; PRODUCT ID 3550-09, LOT # L98575, IMPLANTED: (B)(6) 2001, PRODUCT TYPE ACCESSORY; PRODUCT ID 7435, SERIAL # (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN FEELING STIMULATION WHEN IT WAS NOT EXPECTED. PATIENT EXPLAINED THAT AFTER A MONTH OF THIS UNWANTED STIMULATION THEY HAD DEVELOPED SCAR TISSUE AND A CYST "UNDERNEATH IT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE "MALFUNCTIONED" ABOUT THREE YEARS AGO WHEN THE DEVICE "WOULDN'T TURN OFF" AND THAT WAS THE LAST TIME THE PATIENT USED THE DEVICE. WHEN THE DEVICE WOULD TURN OFF, THE PATIENT WOULD "STILL FEEL THE ELECTRONIC PULSES AND INSTEAD OF COVERING JUST MY RIGHT KNEE, IT STIMULATED MY ABDOMEN AND LEFT KNEE AND THEN IT KEPT SPREADING." IT WAS NOTED THAT THE PATIENT INDICATED THAT THE MANUFACTURER REPRESENTATIVE STATED THAT THE FEELING HAD NOTHING TO DO WITH THE DEVICE, BUT THAT HER DOCTOR THOUGHT IT WAS BECAUSE OF THE DEVICE. IT WAS INDICATED THAT THIS CONDITION LASTED FOR "ABOUT A MONTH AND THEN FINALLY TURNED OFF." IT WAS NOTED THAT THE PATIENT'S DEVICE "WORKED FINE FOR NINE YEARS." ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171514 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1