BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2822332 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-09986
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 9, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE COUPLING AND COMMUNICATION ISSUES, AND THE PATIENT EXPERIENCED A 'WARM SENSATION IN OR AROUND' THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET DURING RECHARGING SESSIONS. IT WAS NOTED THAT IT WAS THE PATIENT'S FIRST TIME RECHARGING AND THE PATIENT INITIALLY HAD 0 SHADED COUPLING BARS AFTER CHARGING THE INS RECHARGER. IT WAS STATED THAT THERE WAS 'POOR COMMUNICATION' WITH BOTH THE RECHARGER AND THE PATIENT PROGRAMMER. THE PATIENT REPORTEDLY FELL AND 'PASSED OUT' DUE TO PNEUMONIA THE WEEKEND PRIOR TO THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1