BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 1971585 · Received January 25, 2011

    Report

    Report Number
    3007566237-2011-00596
    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) - SHORTNESS OF BREATH.

    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 FOLLOW-UP. OF THE TWO MODALITIES, 3 PTS (27%) HAD AN IOP PLACED FIRST AND 8 PTS (73%) HAD A SCS IMPLANTED INITIALLY. MEAN FOLLOW-UP 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 (83%) 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) MALE PT (PT 2) EXPERIENCED A FRACTURE OF THE CONNECTING ELECTRODE OF THEIR SCS REQUIRING SURGERY 63 MONTHS POST PLACEMENT. THE PT ALSO EXPERIENCED CHEST PAIN AND SHORTNESS OF BREATH WHEN THE STIMULATION RATE WAS INCREASED, THIS WAS MANAGED NON-OPERATIVELY. THE PT WAS REPORTED TO BE SATISFIED OVERALL WITH THEIR PAIN MANAGEMENT WITH BOTH THE IOP AND SCS.

    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 49 YR Required Intervention IMPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8637, LOT # UNK| EXPLANTED:| EXPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK| EXPLANTED:| UNK CONVERSION TYPE: MODEL LEAD N, LOT# UNK| IMPLANTED: