BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2872860 · Received December 13, 2012

    Report

    Report Number
    3004209178-2012-11812
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 20, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3387-40 LOT# J0461559V, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3387-40 LOT# V006492, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HE RIGHT SIDE DEVICE WAS GIVING THE PATIENT "ALL SORTS OF IRRITATION." IT WAS STATED THAT THE PATIENT'S SKIN WAS IRRITATED AND SENSITIVE TO THE TOUCH. IT WAS NOTED THAT THE PATIENT HAD BEEN GETTING SHOCKS EVERY "NOW AND THEN" ON HIS RIGHT SIDE FOR THE PAST MONTH. IT WAS ALSO NOTED THAT THE PATIENT FELT SHOCKS DIRECTLY FOLLOWING RIGHT SIDE IMPLANT. THE REPORTER STATED THAT THE HEALTHCARE PROVIDER (HCP) TOOK THE DEVICE OUT, CLEANED IT UP, AND PUT IT BACK IN TO RESOLVE THE ISSUE. THE PATIENT WAS UNABLE TO TURN DOWN STIMULATION WITH CURRENT CLINICIAN SETTINGS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2012. THE CAUSE WAS NOTED AS SHOCKING AT THE DEVICE SITE. THE PROBLEM WAS STATED AS BEING CHRONIC. THE REPORTER STATED THAT FLUID APPEARED TO BE LEAKING INTO CONNECTION PORT. THE PATIENT'S STATUS FOLLOWING REPLACEMENT WAS UNKNOWN. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL 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 00059 YR Required Intervention