BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 6026826 · Received October 13, 2016

    Report

    Report Number
    6000032-2016-00139
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    January 1, 2013
    Report Date
    October 13, 2016
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 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. PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: PROGRAMMER, PATIENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PATIENT CODE (B)(4) WAS ADDED IN ERROR, (B)(4) IS THE CORRECT CODE APPLICABLE TO THE EVENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON 2013-01-18 THE CALLER REPORTS NO STIMULATION SENSATION. ARE THERE SYMPTOMS: YES. THE FOLLOWING SYMPTOMS WERE REPORTED: ACUTE PAIN. PT REPORTS SHE NOTICED SHE WAS HAVING SEVERE BACK PAIN FOR SOMETIME. PT IS NOT SURE WHEN THIS STARTED. PT REPORTS SHE HAS JUST BEEN IN PAIN AND REALIZED LAST NIGHT THAT HER INS HAS DEPLETED. PT REPORTS INS HAS BEEN IN SINCE 2004. ON 2013-01-18 THE CALLER REPORTS A LOSS OF THERAPEUTIC EFFECT. PT REPORTS THAT SHE IN PAIN ALL THE TIME BUT NOTICED WITHIN THE LAST 2 WEEKS IT WAS GETTING WORSE. PT STATED IT WAS "UNBEARABLE LAST WEEK AND THIS WEEKEND." PT NOTED LAST NIGHT ((B)(6) 2013) "IT DAWNED ON ME" THAT IT COULD BE HER INS BECAUSE SHE HAD TRIED ICE PACKS AND NOTHING SEEMED TO HELP HER PAIN. PT REPORT SHE CHECKED INS WITH PROGRAMMER AND ONLY THE 9V BATTERY LIGHT COMES ON. ON 2013-01-18 PT STATES SHE WOULD LIKE TO HAVE HER INS CHECKED. PT STATES SHE HASN'T HAD INS CHECK SINCE 2007. CALLER REPORTS NOT BEING ABLE TO ADJUST STIMULATION. THE STATUS LIGHTS WERE ASSESSED. PT STATES NO LIGHTS WERE SHOWING. DURING CALL PT CHANGED HER 9V BATTER AND STATES SHE COULD HEAR A BEEP. PT WENT TO CHECK INS AND IS SEEING GREEN LIGHT NEXT TO 9V AS STATED IN RELATED CASE. PT STATES SHE DOES NOT HEAR BEEPING WHEN PRESSING ANY KEYS. PT STATES SHE DOESN'T EVER REMEMBER SEEING ANY BLINKING LIGHTS ON THE PROGRAMMER SINCE SHE NEVER REALLY USED IT MUCH. ON 18-MAR-2013 A MANUFACTURING REPRESENTATIVE REQUESTED DEVICE SPECIFICATIONS. A REVISION WAS SCHEDULED FOR THE NEXT DAY AND WAS BEING APPROACHED AS A NORMAL BATTERY DEPLETION AND REPLACEMENT BUT WANTED TO KNOW MORE ABOUT THE LEAD IN CASE THE BATTERY REPLACEMENT TURNED INTO A FURTHER REVISION. ON 2016-09-14 ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT INDICATED THAT THEIR INS MOVED DOWNWARDS, AND CAUSED THEM TROUBLE SITTING, THUS THE IMPLANT WAS REPLACED. THE PATIENT WAS IMPLANTED FOR FAILED BACK SURGERY SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678917 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention