BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2734588 · Received September 7, 2012

    Report

    Report Number
    3007566237-2012-02166
    Event Type
    Injury
    Date Received
    September 7, 2012
    Date of Event
    March 31, 2012
    Report Date
    August 8, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8870AAI, SERIAL# (B)(4), PRODUCT TYPE SOFTWARE, PRODUCT ID 8840, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID 3387S-40, LOT# V815155, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH, PULMONARY EDEMA, AND PAROXYSMAL NOCTURNAL DYSPNEA 2 DAYS FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THIS EVENT WAS UNRELATED TO THE EXTERNAL NEUROSTIMULATOR SYSTEM (ENS) AND COMPONENTS. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM ON (B)(6), 2012 THEN ADMITTED TO THE HOSPITAL ON THE SAME DAY. A DIAGNOSIS OF NON-ST ELEVATION MYOCARDIAL INFARCTION WAS REPORTED. IT WAS NOTED THAT MEDICATIONS WERE ADMINISTERED TO TREAT THE PATIENT FOR THE REPORTED EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE EVENT WAS RELATED TO THE STANDARD OF CARE PROCEDURE (CAROTID ENDARTERECTOMY), AND NOT TO THE STUDY DRIVEN PROTOCOL. THE EVENT WAS CONSIDERED RESOLVED ON (B)(6)-2012, 52 DAYS POST-ONSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37022

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R