BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 4137670 · Received October 3, 2014

    Report

    Report Number
    3004209178-2014-18223
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    December 10, 2007
    Report Date
    September 27, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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

    PRODUCT ID 7435, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 748910, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 748910, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3093-28, LOT# V053455, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3093-28, LOT# V053146, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    DUE TO IMDRF HARMONIZATION, ANY PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES NO LONGER APPLY TO THIS EVENT. 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

    ADDITIONAL INFORMATION REPORTS THERE WAS NOT A FIFTY PERCENT OR GREATER SYMPTOM REDUCTION. IT WAS NOTED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINE AND IT WAS NOT DEVICE RELATED. REPROGRAMMING WAS NEEDED. THE NEUROSTIMUALTOR (IPG) WAS PLACED IN 12/10/07 WITH GOOD RESPONSE. OVERTIME HER RESPONSE WAS LESS DESPITE REPROGRAMMING AND SHE UNDERWENT BLADDER BOTOX INJECTION. IT WAS UNKNOWN IF THE PATIENT EXPERIENCED LOSS OF THERAPEUTIC EFFECT AND UNKNOWN IF THE LOSS WAS SUDDEN OR GRADUAL. ALSO UNKNOWN IF THE PATIENT EXPERIENCED A LOSS OF STIMULATION AND IF IT WAS SUDDEN OR GRADUAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S DOCTOR PUT IN A DEVICE IN 2007 AND IT HAD NEVER BEEN REALLY GOOD. THERE WAS A LOSS OF THERAPEUTIC EFFECT, THE PATIENT NEVER HAD THERAPEUTIC EFFECT, AND THE DEVICE HAD NEVER WORKED. IT WASN¿T FUNCTIONING WELL AND THE PATIENT PROBABLY COULD GET ALONG WELL WITHOUT IT. SHE HAD WORKED WITH HER HEALTHCARE PROFESSIONAL (HCP), THEY MADE ADJUSTMENTS AND IT WORKED FOR A WHILE, THEN IT STOPPED. THEY COULDN¿T GET IT TO A GOOD SPOT. THE PATIENT TURNED THE DEVICE OFF THE MORNING OF THE REPORT AND COULD NOT TELL THE DIFFERENCE. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT SHE HAD NO THERAPEUTIC BENEFIT AND THE IMPLANT DIDN¿T WORK FOR HER SO IT WAS REMOVED. THE INDICATION FOR USE WAS URINARY DYSFUNCTION/SACRAL NERVE STIMULATION.

    Description of Event or Problem · 1

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619602 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention