BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2851588 · Received November 29, 2012

    Report

    Report Number
    3004209178-2012-10955
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 5, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387-40, LOT# J0519661V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT# J0451702V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND THE STIMULATION WAS INTERMITTENT. IT WAS STATED THAT THE DEVICE WAS TURNING ITSELF OFF AND THAT IT OCCURRED ALMOST 'EVERY OTHER DAY.' THE ISSUE WAS NOTICED WITHIN THE MONTH PRIOR TO THE REPORT AND WHEN THE HEALTH CARE PROVIDER (HCP) CHECKED THE DEVICE IT SHOWED THAT THE 'RIGHT' DEVICE WAS TURNING OFF, BUT THE PROGRAMMER DID NOT INDICATE THE 'LEFT' DEVICE TURNING OFF. IT WAS NOTICEABLE WHEN THE DEVICE WAS OFF BECAUSE THE PATIENT BECAME 'FROZEN.' ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. PLEASE SEE RELATED MANUFACTURING REPORT #3004209178-2012-10953. IT WAS UNCLEAR WHICH DEVICE WAS CAUSING WHICH SYMPTOMS.

    Description of Event or Problem · 1

    FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED NOTHING WAS REPORTED TO THE OFFICE UNTIL (B)(4) 2012. THE PATIENT HAD LAST BEEN SEEN ON (B)(6) 2012 AND IMPEDANCE CHECK WAS NORMAL. IT WAS UNKNOWN IF SURGICAL INTERVENTION HAD TAKEN PLACE. IT WAS UNKNOWN IF THE PATIENT REQUIRED HOSPITALIZATION DUE TO THE EVENT. IT WAS NOTED THE PATIENT HAD BEEN SEEKING HELP FROM ANOTHER SURGEON. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURER # 3004209178-2012-10953. IT WAS UNCLEAR WHICH DEVICE WAS CAUSING THE SYMPTOMS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CORRECTED THAT THE PATIENT DID NOT HAD LOSS OF THERAPEUTIC EFFECT.

    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