BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1971603 · Received January 25, 2011

    Report

    Report Number
    3007566237-2011-00623
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 3, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    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 MGMT: 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 A 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 (PT 11) EXPERIENCED A CATHETER OCCLUSION REQUIRING SURGERY 7 MONTHS POST PUMP PLACEMENT. THE PT WAS RECEIVING MORPHINE 5.3 MG/DAY AND WAS REPORTED TO BE VERY SATISFIED OVERALL WITH THEIR PAIN MGMT WITH BOTH THE IOP AND SCS. SEE LITERATURE ARTICLE WITH MFR REPORT# 3007566237201100596.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK| EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8637, LOT# UNK