BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2538984 · Received April 18, 2012

    Report

    Report Number
    3004209178-2012-02436
    Event Type
    Injury
    Date Received
    April 18, 2012
    Date of Event
    March 9, 2007
    Report Date
    April 2, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 37712, SERIAL # (B)(4), BOTH EXTENSIONS, AND THE LEAD SHOWED NO SIGNIFICANT ANOMALIES.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EXTENSION: MODEL 748940, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2012 (B)(6), EXTENSION: MODEL 748940, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2012 (B)(6), PROGRAMMER 7435, SERIAL# (B)(4), LEAD: MODEL 3998, LOT# V011958, IMPLANTED: 2007 (B)(6), EXPLANTED: 2012 (B)(6). (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION AROUND HER IMPLANTABLE NEUROSTIMULATOR (INS) SINCE IMPLANTATION. SYMPTOMS WERE NOTED AS A RASH AND SCABS OVER THE INS SITE. SHE USED A CORTISONE CREAM ON THE SITE REGULARLY. IT WAS ALSO NOTED THAT THE PATIENT HAD A KNEE IMPLANT IN (B)(6) 2011 AND HAD HEALING ISSUES FROM THAT ALTHOUGH HER PHYSICIAN STATED THAT "EVERYTHING LOOKED GOOD ON X-RAY". SUBSEQUENT INFORMATION OBTAINED REPORTED THAT THE PATIENT HAD THE INS SYSTEM EXPLANTED DUE TO THE NEED FOR HER TO HAVE A THORACIC MRI. IT WAS NOTED THAT SHE HAD NOT USED THE INS THERAPY IN SEVERAL YEARS. NO INJURIES WERE REPORTED AND THE PATIENT OUTCOME WAS REPORTED AS RECOVERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention