BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PISCES QUAD PLUS

    MDR report key: 1056448 · Received June 4, 2008

    Report

    Report Number
    2182207-2008-02969
    Event Type
    Injury
    Date Received
    June 4, 2008
    Report Date
    May 5, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K923567
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    JOURNAL REFERENCE: TRENTMAN TL, DODICK DW, ZIMMERMAN RS, BIRCH BD. PERCUTANEOUS OCCIPITAL STIMULATOR LEAD TIP EROSION: REPORT OF 2 CASES. PAIN PHYS 2008; 11(2):253-256. OCCIPITAL NERVE STIMULATION IS AN EMERGING TREATMENT MODALITY FOR REFRACTORY HEADACHE DISORDERS. WE DESCRIBE THE FIRST 2 REPORTED CASES OF PERCUTANEOUS OCCIPITAL STIMULATOR LEAD TIP EROSION. IN BOTH CASES, THE LEAD EROSION OCCURRED MANY MONTHS AFTER IMPLANTATION. ONE PT LOST A SIGNIFICANT AMOUNT OF WEIGHT BETWEEN THE TIME OF IMPLANT AND LEAD EROSION, WHILE THE OTHER PT HAD NO OBVIOUS RISK FACTORS. BOTH PTS RETURNED TO EXCELLENT HEADACHE CONTROL. REPORTABLE EVENT: A WOMAN SUFFERED FROM MEDICALLY INTRACTABLE CHRONIC MIGRAINE. REFERRED FOR A TRAIL OF BILATERAL OCCIPITAL NERVE STIMULATION (ONS). TWO YEARS AFTER SHE WAS IMPLANTED WITH ONS, SHE HAD GASTRIC BYPASS. TWENTY ONE MONTHS LATER, SHE HAD HEADACHE AND DISCOMFORT IN RIGHT OCCIPITAL REGION. A LEAD TIP WAS PROTRUDING THROUGH THE SKIN AND WAS ASSOCIATED WITH A SMALL GRANULOMA. SURGERY WAS PERFORMED, THE GRANULOMA EXCISED AND CULTURED WHICH REVEALED INFECTION. THE WOUND WAS CLOSED OVER THE TIP, SHE WAS TREATED WITH ANTIBIOTICS AND HEALED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PISCES QUAD PLUS GZB MEDTRONIC NEUROMODULATION 3888 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention IPG MODEL UNK N=1| PROGRAMMER MODEL UNK N=1| LEAD MODEL 3888 N=1