BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3953058 · Received July 23, 2014

    Report

    Report Number
    3007566237-2014-02062
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN ALLERGIC REACTION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANT AREA. THE REPORTER STATED THE REACTION WAS RELIEVED BY ANTI-ALLERGIC MEDICATION AND ANTIHISTAMINE. THE REPORTER FURTHER STATED THAT IT WAS THE HEALTHCARE PROFESSIONAL¿S OPINION THAT IT WAS AN ALLERGIC REACTION. IT WAS NOTED THE HCP FOUND THE IMPLANT AREA ¿AS AN FIBROUS CAPSULE.¿ IT WAS FURTHER NOTED THE PATIENT¿S INS WAS EXPLANTED AND A NEW INS WAS IMPLANTED. IT WAS NOTED THE LEAD WAS STILL IN USE. THE REPORTER STATED THERE WAS A FIBROUS CAPSULE AT THE IMPLANT AREA AND THE PATIENT HAD PAIN AT THE IMPLANT ARE. THE REPORTER FURTHER STATED THE PATIENT HAD NO INFECTION AND THEY WERE NEGATIVE FOR BACTERIA. IT WAS NOTED THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430091 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37713 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention