BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTIMULATOR

    MDR report key: 2447886 · Received February 13, 2012

    Report

    Report Number
    3007566237-2012-00296
    Event Type
    Injury
    Date Received
    February 13, 2012
    Date of Event
    January 3, 2011
    Report Date
    January 20, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF CONCOMITANT MEDICAL PRODUCTS: IMPLANTED: UNK EXPLANTED: UNK. THE EXACT EVENT DATES WERE NOT PROVIDED. THIS IS AN ESTIMATE BASED ON THE DATE THE ARTICLE WAS RECEIVED FOR PUBLICATION. IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: CHINCHOLKAR, MAHINDRA, SAM ELDABE, ROGER STRACHAN, MORAG BROOKES, FAY GARNER, RAYMOND CHADWICK, ASHISH GULVE, AND JILL NESS. "PROSPECTIVE ANALYSIS OF THE TRIAL PERIOD FOR SPINAL CORD STIMULATION TREATMENT FOR CHRONIC PAIN." NEUROMODULATION: TECHNOLOGY AT THE NEURAL INTERFACE 14.6 (2011): 523-28. PRINT. SUMMARY: THE AUTHORS PERFORM A RETROSPECTIVE ANALYSIS ON FORTY PATIENTS WHO UNDERWENT TRIALING PERIOD FOR SPINAL CORD STIMULATION. THE OBJECTIVE OF THE STUDY WAS TO DETERMINE PATIENT PREFERENCES REGARDING THE DURATION OF TRIAL PERIOD AND ITS IMPACT ON THE SUCCESS OF THE THERAPY. IT WAS DETERMINED THAT ALL PATIENTS COULD MAKE A DECISION IN 15 DAYS, WITH SUCCESSFUL TRIALS REQUIRING A SHORTER DURATION. REPORTED EVENTS: FOUR PATIENTS DEVELOPED LEAD MIGRATION WHICH REQUIRED SURGICAL INTERVENTION. ONE PATIENT HAD A LEAD FRACTURE WHICH REQUIRED SURGICAL INTERVENTION. ONE PATIENT PRESENTED WITH A DEPLETED IPG WITHIN THE FIRST 12 MONTHS. TWO PATIENTS DEVELOPED INFECTIONS DURING THE TRIAL PERIOD WHICH NECESSITATED SURGICAL INTERVENTION. ONE PATIENT DEVELOPED INFECTION DURING THE PERMANENT IMPLANT STAGE. FURTHER INFORMATION IS BEING REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL NEU_UNKNOWN_LEAD LOT# UNK SERIAL# UNK