BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2210528 · Received August 10, 2011

    Report

    Report Number
    3004209178-2011-06231
    Event Type
    Injury
    Date Received
    August 10, 2011
    Report Date
    July 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEUROSTIMULATOR HAD MIGRATED AS THE POCKET AND THE PATIENT'S BREASTS HAD SAGGED. THE MIGRATION OF THE NEUROSTIMULATOR ALSO CAUSED TRACTION ON THE LEADS. THEREFORE, WHEN THE NEUROSTIMULATORS WERE REPLACED FOR NORMAL BATTERY DEPLETION ON (B)(6) 2011, THE EXISTING POCKET SITES WERE SUTURED AND NEW POCKETS WERE MADE MORE CRANIALLY. IT WAS NOTED THAT THE PATIENT REQUIRED HOSPITALIZATION DUE TO THE EVENT. THE PATIENT WAS NOTED TO HAVE INCURRED NON-SERIOUS INJURY/ILLNESS AND RECOVERED WITHOUT SEQUELA. REFER TO MANUFACTURER REPORT 3004209178201106232.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| LOT# NFW139683H| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# J0225534V| EXPLANTED:| LEAD: MODEL 3387, LOT# J0225510V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK020583V| EXTENSION: MODEL 7495LZ, LOT# NHK020584V| EXPLANTED: