BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3122982 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-08015
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    September 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3387S-40 LOT# V203702, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3387S-40 LOT# V203702, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A STAPH INFECTION THAT REQUIRED HIS FIRST DEVICE TO BE TAKEN OUT. IT WAS STATED THAT THE SYSTEM WAS IMPLANTED IN (B)(6) 2009 AND MIGHT HAVE BEEN TAKEN OUT IN (B)(6) 2011, ALTHOUGH IT WAS UNCLEAR, AND MANUFACTURER DATABASE ALSO DID NOT REFLECT THAT. IT WAS STATED THAT NO ONE KNEW WHY, BUT THE INFECTION GOT ON THE LEAD AND DIDN'T GO TO BRAIN, SO, AS A PRECAUTION "THEY TOOK THE WHOLE THING OUT." IT WAS UNCLEAR IF THIS REFERRED TO THE WHOLE SYSTEM OR JUST THE IMPLANTABLE NEUROSTIMULATOR (INS), BUT, ACCORDING TO THE MANUFACTURER DATABASE, IT MIGHT HAVE BEEN JUST THE INS. IT WAS ALSO NOTED THAT "THIS WAS NOT A PRODUCT DEFECT BUT RATHER AN INFECTION PROBLEM." IT WAS ALSO NOTED THAT THE PATIENT HAD A GOOD THERAPEUTIC BENEFIT PRIOR TO THE EXPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225122 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention