BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4672366 · Received April 9, 2015

    Report

    Report Number
    3004209178-2015-06229
    Event Type
    Injury
    Date Received
    April 9, 2015
    Date of Event
    January 9, 2006
    Report Date
    March 22, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 377860, LOT# N0052270, IMPLANTED: 2006-(B)(6), PRODUCT TYPE: LEAD. PRODUCT ID: 377860, LOT# V001729, IMPLANTED: 2006-(B)(6), PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED DURING IMPLANT BOTH WOUNDS WERE IRRIGATED WITH COPIOUS AMOUNTS OF ANTIBIOTIC SOLUTION. NO OTHER PERI OPERATIVE ANTIBIOTICS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SUPERFICIAL INFECTION OF LEFT BUTTOCK. SYMPTOMS INCLUDED A TEMPERATURE OF 99.2 WITHOUT ERYTHEMA ON (B)(6) 2006. THERE WAS SLIGHT ERYTHEMA AT THE POSTERIOR INCISION ON THE LEFT ON (B)(6) 2006 AND ON (B)(6) 2006 ERYTHEMA WAS STILL PRESENT, SLIGHT PUSTULAR AREA LEFT LATERAL MARGIN OF WOUND. ON (B)(6) 2006 THERE WAS NO ERYTHEMA. THIS WAS RELATED TO THE DEVICE OR THERAPY AND WAS RELATED TO THE IMPLANT PROCEDURE. THERE WAS AN EXAMINATION/PALPATION ALONG WITH LAB WORK WITH RESULTS THAT INDICATED C-REACTIVE PROTEIN AT 46.1, WHITE BLOOD COUNT 6.8, AND SED RATE 67. INTERVENTION INCLUDED CLINDAMYCIN AT 300MG THREE TIMES A DAY FOR 4 DAYS AND BACTRIM DS ORALLY TWICE A DAY FOR 7 DAYS. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234325 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention