BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2994331 · Received March 8, 2013

    Report

    Report Number
    3006630150-2013-00418
    Event Type
    Injury
    Date Received
    March 8, 2013
    Report Date
    February 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2013.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE POST IMPLANT PROCEDURE THE PATIENT EXPERIENCED AN INCREASED FREQUENCY ANGINA, WHICH WAS A PRE-EXISTING CONDITION. THE SYMPTOMS RELIEVED AFTER USE OF SUBLINGUAL NITROGLYCERIN AND REST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98622 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention