BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3122442 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07980
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    May 3, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387S-40, LOT# V419196, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V657037, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V657037, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7438, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3387S-40, LOT# V419196, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO ANOMALY. THE DEVICE FUNCTIONED PROPERLY DURING THE LONG TERM MONITOR TEST. THE DEVICE WAS SET TO THE PARAMETERS THE EXPLANTED DEVICE HAD WHEN RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THEIR DEVICE BATTERIES EXPLANTED. IT WAS STATED THE PATIENT¿S DEVICE BATTERIES WOULD TURN OFF AND ON UNEXPECTEDLY. UPON DEVICE INTERROGATION, THE PATIENT¿S HEALTH CARE PROVIDER NOTED 168 ACTIVATIONS IN THE PREVIOUS MONTH. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE MFR. REPORT # 3004209178-2013-07979 FOR INFORMATION ABOUT THE PATIENT¿S OTHER DEVICE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224661 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention