BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2875528 · Received December 17, 2012

    Report

    Report Number
    3004209178-2012-11906
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Report Date
    November 28, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT # V230715, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT # V230715, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THIS WAS A BILATERAL SYSTEM. REFERENCE MFR 3004209178-2012-11904.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE WIRES FELT TIGHT AND PAINFUL. THE REPORTER STATED THAT IT WAS BELIEVED THAT THIS STARTED RIGHT AFTER THE PATIENT HAD A CERVICAL FACET INJECTION. IT WAS REPORTED THAT IF THE PATIENT "FOLLOWED THE LEAD UP"COMING FROM THE RIGHT BACK TO HER NECK, IT WAS VERY PAINFUL. THE REPORTER STATED THAT BEFORE THE PATIENT WAS NOT ABLE TO SEE THE LEAD AND NOW SHE COULD CLEARLY SEE IT. IT WAS DESCRIBED AS "VERY TORQUE AND TIGHT IN HER NECK." IT WAS UNCLEAR WHAT WAS MEANT BY "VERY TORQUE." IT WAS NOTED THAT THE NIGHT BEFORE THE REPORT THE PATIENT HAD A FEVER, PAIN IN HER BACK/SPINE, AND HAD NOT BEEN ABLE TO SLEEP THE LAST TWO NIGHTS BECAUSE OF THE PAIN AND HEADACHES. THE REPORTER STATED THAT THE LEAD WAS TIGHT, SORE, IT WAS SWOLLEN AROUND IT, AND THE PATIENT COULDN'T TURN HER HEAD COMPLETELY TO THE LEFT. IT WAS REPORTED THAT THE FACET INJECTION MAY HAVE CAUSED THE PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. SEE MFR REPORT # 3004209178-2012-11904 IT WAS UNCLEAR WHICH DEVICE WAS PART OF THE EVENT.

    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