BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2876418 · Received December 17, 2012

    Report

    Report Number
    3004209178-2012-11959
    Event Type
    Injury
    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
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 748240 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 748240 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3387S-40 LOT# V012262, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3387S-40 LOT# V014191, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A POCKET EROSION AND INFECTION OF THE LEFT IMPLANTABLE NEUROSTIMULATOR (INS). ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD A REVISION/REPOSITIONING OF THE INS ON (B)(6) 2012. THE PATIENT FELT GOOD WITH GOOD TREMOR CONTROL. IT WAS NOTED THAT A NEW 95CM EXTENSION WAS TUNNELED DOWN THE PATIENT'S LEFT BACK TO A NEW INS LOCATED ON THE LOWER BACK. IT WAS UNCLEAR IF THE ORIGINAL POCKET WAS CULTURED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER REPORTED THAT THE CAUSE OF THE EVEN WAS SKIN EROSION OVER THE IMPLANTABLE NEUROSTIMULATOR (INS). A NEW INS WAS IMPLANTED. THE REVISION PROCEDURE HAPPENED ON (B)(6)-2012 WHERE REPLACEMENT AND REPOSITIONING OF THE INS OCCURRED. THE PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT WAS REPORTED AS SKIN BREAKDOWN. THERE WAS NO PATIENT HOSPITALIZATION. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELA.

    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 Required Intervention