BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2894987 · Received October 29, 2010

    Report

    Report Number
    3007566237-2010-08666
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    July 6, 2010
    Report Date
    October 5, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ATORVASTATIN; 10 MG;QD; (B)(6) 2007 - PRESENT; BACLOFEN; 10MG;TID (B)(6) 2004 - PRESENT; DIAZEPAM; 5MG; TID; (B)(6) 2006 - PRESENT; HYDROCODONE-ACETAMINOPHEN; 10MG;QD; (B)(6) 2009 - PRESENT; MORPHINE; 30 MG CAP; QD; (B)(6) 2008 - PRESENT; SERTRALINE; 100MG; QD; (B)(6) 2007 - PRESENT; DYAZIDE; 25 MG CAPSULE; QD; (B)(6) 2007 - PRESENT; TRIHEXYPHENIDYL; 4 MG; TID; (B)(6) 2009 - PRESENT; ASPIRIN; 81MG; QD; (B)(6) 2007 - PRESENT; MULTIVITAMIN; 1 TABLET; QD; (B)(6) 2007 - PRESENT. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    A MEDWATCH REPORT INDICATED THAT TWO OPEN CIRCUITS WERE DETECTED DURING A PT'S ROUTINE CLINIC VISIT ON (B)(6) 2010. THE OPEN CIRCUITS WERE THOUGHT TO HAVE CAUSED A REDUCED THERAPEUTIC BENEFIT. THE PT'S IMPLANTED PULSE GENERATOR (IPG) WAS PREVIOUSLY REPLACED ON (B)(6) 2010, DUE TO AN EXPIRING BATTERY. IT WAS NOTED THAT AN AFFECTED DEEP BRAIN STIMULATOR LEAD HAD BEEN ORIGINALLY IMPLANTED ON(B)(6) 2005. AN X-RAY DID NOT REVEAL ANY LEAD OR WIRE FRACTURE. THE PT WENT TO AN OPERATING ROOM TO HAVE THEIR ENTIRE RIGHT DEEP BRAIN STIMULATOR SYS (IPG AND LEAD) REVISED DUE TO THE OPEN CIRCUITS. THE PT'S OUTCOME WAS NOT REPORTED. ADD'L INFO IS BEING REQUESTED, AND WILL BE PROVIDED IN A F/U REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC NEUROMODULATION 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention LEAD: MODEL 3387, LOT# UNK| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL UNK, LOT# UNK