BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2930900 · Received January 28, 2013

    Report

    Report Number
    3007566237-2013-00283
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. THE PATIENT DID NOT HAVE MENINGITIS. SIGNS AND SYMPTOMS INCLUDED REDNESS, DRAINAGE AND INCISIONAL WOUND OPENING. THE PRIMARY LOCATION OF THE INFECTION WAS THE DEVICE POCKET. THE ORGANISM CULTURED WAS (B)(6). BOTH INTRAVENOUS AND ORAL ANTIBIOTICS WERE GIVEN. THERE WAS A PARTIAL DEVICE SYSTEM EXPLANT AND THE INFECTION RESOLVED. IT WAS NOTED THE PATIENT WOULD TAKE ORAL ANTIBIOTICS FOR ANOTHER 6 WEEKS. DIABETES WAS A RISK FACTOR THAT APPLIED TO THE PATIENT PRIOR TO IMPLANTATION OF THE DEVICE. IT WAS NOTED THE PATIENT HAD "SEVERELY DRY SKIN AND LAYERS OF FLAKING". IT WAS ALSO NOTED THE PATIENT WOULD HAVE ANOTHER FOLLOW UP (B)(6) 2013. IT WAS REPORTED THE PATIENT HAD BEEN HAVING "A LOT OF TROUBLE WITH THEIR BATTERIES, BUT NOW THEY DID NOT HAVE BATTERY IN".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE WAS IMPLANTED IN (B)(6) AND THE IMPLANT NEVER HEALED AND IT POKED THROUGH THE SKIN. THE DEVICE WAS REMOVED ON (B)(6) 2012 DUE TO A STAPH INFECTION. IT WAS NOTED THAT THE PATIENT WANTED TO KNOW HOW TO GET ANOTHER DEVICE IMPLANTED. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36637 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention