BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 1971571 · Received January 25, 2011

    Report

    Report Number
    3007566237-2011-00606
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 3, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AT THIS TIME NO ADDITIONAL INFO WAS AVAILABLE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: TOMYCZ ND, ORTIZ V, MOOSSY JJ. SIMULTANEOUS INTRATHECAL OPIOID PUMP AND SPINAL CORD STIMULATION FOR PAIN MANAGEMENT: ANALYSIS OF 11 PTS WITH FAILED BACK SURGERY SYNDROME. J PAIN PALLIAT CARE PHARMACOTHER. DEC 2010;24(4):374-383. SUMMARY: THE AUTHORS PERFORMED A RETROSPECTIVE REVIEW OF 11 PTS (8 MEN, 3 WOMEN) WITH FAILED BACK SURGERY SYNDROME (FBSS) WHO UNDERWENT NONSIMULTANEOUS SURGICAL IMPLANTATION OF BOTH AN INTRATHECAL OPIOID PUMP (IOP) AND A THORACIC SPINAL CORD STIMULATOR (SCS). CHART REVIEW AND STRUCTURED PHONE INTERVIEWS WERE PERFORMED TO OBTAIN F/U. OF THE TWO MODALITIES, 3 PTS (27%) HAD AN IOP PLACED FIRST AND 8 PTS (73%) HAD AN SCS IMPLANTED INITIALLY. MEAN F/U WAS 41.7 MONTHS (3-97 MONTHS). ALL 11 PTS (100%) STATED THAT THE DUAL-MODALITY TREATMENT IMPROVED THEIR QUALITY OF LIFE AND ALL CONTINUE TO USE BOTH AN IOP AND SCS FOR PAIN CONTROL. SIX PTS (55%) FELT THAT THE IOP PROVIDED SUPERIOR PAIN RELIEF AS COMPARED TO THE SCS, 4 PTS (36%) FELT THAT IOP AND SCS PROVIDED A SIMILAR DEGREE OF PAIN RELIEF, AND 1 PT (9%) SAID THE SCS PROVIDED BETTER PAIN RELIEF THAN THE IOP. NINE PTS (82%) CLAIMED THAT DUAL-MODALITY TREATMENT IMPROVED THEIR ACTIVITIES OF DAILY LIVING. NINE PTS (82%) REPORTED THAT THE COMBINATION OF IOP AND SCS TREATMENT HAD ALLOWED THEM TO SIGNIFICANTLY DECREASE THEIR ORAL PAIN MEDICATION REQUIREMENTS. REPORTABLE EVENT: ONE (B)(6) FEMALE PT EXPERIENCED POOR STIMULATION COVERAGE REQUIRING SURGERY 24 MONTHS POST SCS PLACEMENT. THE PT REPORTED TO BE VERY SATISFIED OVERALL WITH THEIR PAIN MANAGEMENT WITH BOTH THE IOP AND SCS. SEE LITERATURE ARTICLE WITH MFR REPORT# 3007566237-2011-00596.

    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 38 YR Required Intervention EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTABLE PULSE GENERATOR: MODEL IPGNEURO,| IMPLANTED:| IMPLANTED:| LOT# UNK| CATHETER: MODEL CATHETER, LOT# UNK| LEAD TYPE: MODEL LEADN, LOT# UNK