BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PISCES QUAD PLUS

    MDR report key: 1056450 · Received June 4, 2008

    Report

    Report Number
    2182207-2008-02970
    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 WITH LEFT OCCIPITAL AND PARIETAL REGION HEADACHES. SHE UNDER WENT AN ONS TRAIL WITH UNILATERAL PERCUTANEOUS LEAD. DURING TRIAL SHE HAD COMPLETE PAIN RELIEF AND WAS IMPLANTED WITH A PERMANENT SYSTEM 1 MONTH LATER. SIX MONTHS LATER, SHE COMPLAINED OF SORENESS AND A PALPABLE LEAD TIP IN THE RETROMASTOID REGION. THERE WAS NO INFECTION AND A PALPABLE LEAD TIP IN THE RETROMASTOID REGION. THERE WAS NO INFECTION AND OBSERVATION WAS ADVISED. IN 16 MONTHS LATER, SHE PRESENTED WITH 2 WEEKS OF DISCOMFORT AND ACUTE LEAD TIP EROSION WITH LOCALIZED INFECTION. THE LEAD WAS REMOVED, SHE WAS TREATED WITH ANTIBIOTICS AND 1 MONTH LATER, THE LEAD WAS REPLACED.

    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 41 YR Required Intervention PROGRAMMER MODEL UNK N=1| IMPLANTABLE PULSE GENERATOR MODEL UNK N=1| LEAD MODEL 3888 N=1