BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2129777 · Received June 7, 2011

    Report

    Report Number
    3007566237-2011-04067
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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.

    Description of Event or Problem · 1

    LITERATURE: ANEJA S, TAYLOR JS, BILLINGS SD, HONARI G, SOOD A. POST-IMPLANTATION ERYTHEMA IN 3 PTS AND A REVIEW OF RETICULAR TELANGIECTATIC ERYTHEMA. CONTACT DERMATITIS. MAY 2011;64(5):280-288. SUMMARY: THE AUTHORS REVIEW THE APPEARANCE OF ERYTHEMATOUS, BLANCHABLE PATCHES OR PLAQUES OVERLYING AN IMPLANT AND SUGGEST POSSIBLE DIAGNOSIS OF RETICULAR TELANGIECTATIC ERYTHEMA (RTE). THE AUTHORS DEMONSTRATE THE CLINICAL PRESENTATION OF RTE OR SIMILAR PATCH TEST-NEGATIVE POST-IMPLANTATION ERYTHEMA. EVENT: THE AUTHORS REPORT ON A (B)(6) MALE (CASE 2) THAT PRESENTED WITH A 3-WEEK HISTORY OF WARM RETICULAR ERYTHEMATOUS PATCH OVER THE RIGHT SIDE OF HIS ABDOMEN. HE PREVIOUSLY HAD TWO METAL RODS, A SPINAL CORD STIMULATOR REPLACEMENT (T8-9) AND A PULSE GENERATOR IMPLANTED WITHOUT ANY CUTANEOUS COMPLICATIONS, 8 MONTHS EARLIER. HE DESCRIBED THE AFFECTED AREA AS INTERMITTENTLY ITCHY AND SWOLLEN, BUT DID NOT COMPLAIN OF ANY PAIN. THE PT WAS TREATED WITH CLINDAMYCIN 300 MG, AND NOTICED A TRANSIENT IMPROVEMENT IN REDNESS. A SKIN BIOPSY REVEALED SUPERFICIAL PERIVASCULAR AND INTERSTITIAL LYMPHOCYTIC INFILTRATE ASSOCIATED WITH SMUDGING OF THE DERMOEPIDERMAL JUNCTION AND THE PRESENCE OF A FEW DYSKERATOTIC KERATINOCYTES. PATCH TESTS WITH AN ABBREVIATED SCREENING AND PROSTHESIS SERIES WERE ALL NEGATIVE. THE ABSENCE OF MUCIN EXCLUDED A DIAGNOSIS OF RETICULAR ERYTHEMATOUS MUCINOSIS. THERE WAS NO HISTORY OF HEAT APPLICATION TO THE SITE, WHICH ARGUED AGAINST ERYTHEMA AB IGNE AND NARROWED THE DIFFERENTIAL DIAGNOSIS TO RTE. IN SUBSEQUENT FOLLOW-UP APPOINTMENTS, THE AFFECTED SKIN AREA DID NOT SIGNIFICANTLY IMPROVE, AND IT APPEARED THAT THE EFFICACY OF THE SPINAL CORD STIMULATOR WAS DECLINING. THE ORTHOPAEDIC SURGEON WAS PROMPTED TO REPLACE THE IMPLANTED DEVICES; THREE DAYS AFTER THIS, AN ERYTHEMATOUS PATCH AGAIN DEVELOPED OVER THE RIGHT FLANK AREA, SUGGESTING THAT THE DEVICES COULD NOT ACCOUNT FOR THE SKIN ERUPTION. NO FOLLOW-UP INFO WAS AVAILABLE.

    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 66 YR Required Intervention LEAD UNKNOWN