BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2652324 · Received July 12, 2012

    Report

    Report Number
    3004209178-2012-05477
    Event Type
    Malfunction
    Date Received
    July 12, 2012
    Report Date
    June 13, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 3389S-40, LOT# V050299, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 3389S-40, LOT# V084682, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IRRITATION AND BURNING WAS THOUGHT TO BE A MUSCLE STRAIN. THE PATIENT'S FAMILY MEMBER WAS CONVINCED THAT THERE WAS "NOTHING ELSE TO IT OTHER THAN A MUSCLE STRAIN." THE REPORTER STATED THAT THE SYMPTOMS REOCCURRED WHILE THE PATIENT WAS RIDING A BIKE. THE HEALTH CARE PROFESSIONAL (HCP) STATED SHE DID NOT FEEL THAT THIS INCIDENT WAS DEVICE RELATED. NO ADDITIONAL INFORMATION WAS REPORTED. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE STIMULATION WAS ON, THE PATIENT EXPERIENCED A BURNING SENSATION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITES. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. THE PAIN WAS BILATERAL AND STARTED THAT MORNING. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM. THE PATIENT HAD NEVER TURNED THE INSS OFF. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1