BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4791963 · Received May 22, 2015

    Report

    Report Number
    3007566237-2015-01405
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    January 20, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT PRODUCTS: PRODUCT ID: 39565, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 39565, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    PAHAPILL, P.A. A NOVEL NONANCHORING TECHNIQUE FOR IMPLANTATION OF PADDLE LEADS IN THE CERVICAL SPINE UNDER CONSCIOUS SEDATION. NEUROMODULATION : JOURNAL OF THE INTERNATIONAL NEUROMODULATION SOCIETY. 2015. DOI:10.1111/NER.12283. SUMMARY: SPINAL CORD STIMULATION (SCS). REVISION SURGERY REMAINS COMMON, WITH A NEGATIVE IMPACT ON COST-EFFECTIVENESS AND OUTCOMES. THE PRIMARY GOAL OF THIS REPORT WAS TO RETROSPECTIVELY STUDY THE NEED FOR REVISION SURGERY IN A COHORT OF COMPLEX REGIONAL PAIN SYNDROME TYPE I (CRPS-1) PATIENTS WITH NEWLY IMPLANTED CERVICAL SURGICAL PADDLE LEADS, FOCUSING ON A METHOD OF IMPLANTATION TO REDUCE THE NEED FOR REVISION SURGERY. FIFTEEN PATIENTS UNDERWENT IMPLANTATION OF PADDLE SCS LEADS IN THE CERVICAL SPINE WITH CERVICAL LAMINOTOMIES UNDER CONSCIOUS SEDATION FOR CRPS-1 FROM 2008 TO 2012. ELECTRODES WERE NOT ANCHORED AND 11 OF THE ELECTRODES WERE THREE-COLUMN PADDLE LEADS. A DISINTERESTED THIRD PARTY PERFORMED INITIAL CHART REVIEWS, SUPPLEMENTED BY SUBSEQUENT TELEPHONE INTERVIEWS. THE NEED FOR REVISION SURGERY WAS THE ENDPOINT. A SINGLE SURGEON PERFORMED ALL IMPLANTS WITH A CONSISTENT METHOD. THERE WERE NO PADDLE ELECTRODE LEAD REVISIONS REQUIRED FOR SUBOPTIMAL LEAD PLACEMENT, FRACTURE, MIGRATION, OR INFECTION AT A MEDIAN FOLLOW-UP PERIOD OF 22 MONTHS. THIS STUDY IS THE FIRST TO REPORT ON: 1) CERVICAL ELECTRODE IMPLANTATION WITH NO ANCHORING; AND 2) CERVICAL PADDLE LEAD IMPLANTATION (INCLUDING THREE-COLUMN PADDLES) PERFORMED UNDER CONSCIOUS SEDATION. THE SPECIFIC METHOD OF NONANCHORING OF THE PADDLE IMPLANTS UNDER CONSCIOUS SEDATION MAY HAVE CONTRIBUTED TO LOW ELECTRODE LEAD REVISION RATES. REPORTED EVENT: 2 PATIENTS HAD SUSPECTED BUT NOT CONFIRMED SUPERFICIAL SKIN INFECTIONS THAT WERE TREATED EMPIRICALLY WITH ORAL ANTIBIOTICS AS OUTPATIENTS WITH COMPLETE RESOLUTION IN BOTH CASES. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: MEDTRONIC SPECIFY 5-6-5 LEAD MODEL 39565 (9 PATIENTS), MEDTRONIC SPECIFY 2X8 LEAD MODEL 39286 (1 PATIENT) AND MEDTRONIC SPECIFY 2X4 LEAD MODEL 3998 (2 PATIENTS) FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334342 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention