BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3230397 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-11873
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    June 24, 2013
    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 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE CATHETER LUMBAR INCISION SITE. EXAMINATION OR PALPATION OF THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE ON (B)(6) 2013 INDICATED AN INFECTION. ON THAT SAME DAY, LABORATORY TESTS WERE DONE AND RESULTS SHOWED CBC WAS NORMAL EXCEPT RDW_CV WHICH WAS 15.2. THE PATIENT WAS ADMINISTERED CLINDAMYCIN 300MG 1 QID FOR 7 DAYS ON THAT DAY. EXAMINATION OR PALPATION A WEEK LATER DID NOT SHOW MUCH IMPROVEMENT. THE PATIENT WAS SUBSEQUENTLY ADMINISTERED LEVAQUIN 750MG I DAILY FOR 10 DAYS ON (B)(6) 2013. APPROXIMATELY 3 WEEKS LATER, EXAMINATION SHOWED THE WOUND SITE HAD IMPROVED AND IT NO LONGER LOOKED INFECTED BUT WAS STILL OPEN. THE LEVAQUIN WAS CONTINUED FOR 10 MORE DAYS ON (B)(6) 2013. ON THAT SAME DAY, LABORATORY RESULTS SHOWED "MANY" STAPH AUREUS. THE EVENT WAS INDICATED TO HAVE BEEN UNLIKELY RELATED TO DEVICE OR THERAPY AND POSSIBLY RELATED TO IMPLANT PROCEDURE. SIGNS AND SYMPTOMS INCLUDED SLIGHT DRAINAGE, AN OPEN INCISION ON (B)(6) 2013 AND ERYTHEMA AT THE LUMBAR INCISION SITE. THE OUTCOME WAS INDICATED AS ONGOING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED INDICATED THAT THERE WAS INFECTION AT LUMBAR INCISION SITE AND NOT AT CATHETER LUMBAR INCISION SITE, AS HAD BEEN PREVIOUSLY REPORTED. THE OUTCOME WAS MARKED AS RESOLVED WITHOUT SEQUELAE ON (B)(6)-2013. EXAMINATION/PALPATION RESULTS SHOWED THAT THE INCISION SITE WAS WELL HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329047 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention