BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2031367 · Received March 16, 2011

    Report

    Report Number
    3007566237-2011-01989
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 10, 2010
    Report Date
    February 17, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL THE PTS. AT THIS TIME NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: COSTANTINI A, BUCHSER E, VAN BUYTEN JP. SPINAL CORD STIMULATION FOR THE TREATMENT OF CHRONIC PAIN IN PTS WITH LUMBAR SPINAL STENOSIS. NEUROMODULATION: TECHNOLOGY AT THE NEURAL INTERFACE. 2010;13(4);275-280. SUMMARY: DATA WERE COLLECTED PROSPECTIVELY IN THREE INDEPENDENT REGISTRIES IN THREE EUROPEAN CENTERS (B)(4). PT SELECTION INCLUDED INDIVIDUALS THAT USED SPINAL CORD STIMULATION (SCS) TO CONTROL BACK AND LEG PAIN ATTRIBUTED TO LUMBAR SPINAL STENOSIS (LSS). PTS IN THIS STUDY EITHER HAD DECLINED OR WERE REFUSED FOR SURGERY, AND SCS WAS THOUGHT TO BE A REASONABLE ALTERNATIVES (27) AS THE TREATMENT DOES NOT PREVENT FUTURE SURGERY, SHOULD AN OPERATION BE REQUIRED BECAUSE OF THREATENING NEUROLOGIC DEFICIT. DATA FROM 69 PTS (37 MALES, 54%) WITH INTRACTABLE CHRONIC PAIN ASSOCIATED WITH LSS AND IMPLANTED WITH A SPINAL CORD STIMULATOR SYSTEM BETWEEN (B)(6) 1997 AND (B)(6) 2005 WERE COLLECTED. NO PT HAD PROGRESSIVE NEUROLOGIC DYSFUNCTION. ALL THESE PTS FAILED CONVENTIONAL TREATMENT INCLUDING EPIDURAL STEROID INJECTIONS. IN THIS STUDY GROUP, THE MEAN AGE AT IMPLANT WAS 70 YEARS. REPORTABLE EVENTS: IT WAS REPORTED THAT FIVE PTS EXPERIENCED EARLY (N=2) AND LATE (N=3) LEAD DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL EXTENSION, LOT# UNK| EXPLANTED:| IMPLANTED:| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK| EXPLANTED:| EXTENSION: MODEL EXTENSION, LOT# UNK| EXPLANTED:| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK| IMPLANTED:| EXPLANTED:| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK| EXTENSION: MODEL EXTENSION, LOT# UNK| IMPLANTED:| LOT# UNK| IMPLANTABLE PULSE GENERATOR: MODEL IPGNEURO| EXPLANTED:| LOT# UNK| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL EXTENSION, LOT# UNK| IMPLANTED:| LOT# UNK| IMPLANTABLE PULSE GENERATOR: MODEL IPGNEURO| IMPLANTED:| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK| EXTENSION: MODEL EXTENSION, LOT# UNK| IMPLANTABLE PULSE GENERATOR: MODEL IPGNEURO| EXPLANTED:| LOT# UNK| IMPLANTED:| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE PULSE GENERATOR: MODEL IPGNEURO| IMPLANTED:| EXPLANTED:| IMPLANTED: