BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3090387 · Received May 2, 2013

    Report

    Report Number
    3004209178-2013-07228
    Event Type
    Injury
    Date Received
    May 2, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S WOUNDS DID NOT HEAL AFTER IMPLANT. THE IMPLANTABLE NEUROSTIMULATOR (INS) AND PADDLE LEAD WERE EXPLANTED. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD METHICILLIN RESISTANT STAPH AUREUS (MRSA), WHICH WAS THE REASON FOR THE EXPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INFECTION BEGAN ON (B)(6) 2013. IT WAS STATED THAT PREOPERATIVE ANTIBIOTICS WERE GIVEN (VIA INTRAVENOUS AND ORAL). IT WAS ADDED THAT THE PATIENT EXPERIENCED FEVER, REDNESS, SWELLING, DRAINAGE, PAIN, AND INCISIONAL WOUND OPENING. THE PRIMARY SITE FOR INFECTION WAS REPORTEDLY THE POCKET SITE AND LEAD TRACK. A CULTURE WAS OBTAINED AND THE ORGANISM WAS FOUND TO BE (B)(6). THE ENTIRE SYSTEM WAS EXPLANTED AND THE PATIENT OUTCOME WAS REPORTEDLY ONGOING. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF INFECTION AND WAS DIFFICULT TO TREAT. IT WAS ALSO NOTED THAT DURING THE PATIENT¿S (B)(6) 2013 OFFICE VISIT, THE PATIENT WAS HEALING WELL AND THERE WERE NO SIGNS OF INFLAMMATION OR INFECTION, BUT THE PATIENT DID EXPERIENCE PAIN. THE PATIENT¿S PERIPHERALLY INSERTED CENTRAL CATHETER (PIC LINE) WAS REMOVED AND LABS WERE RETAKEN. IT WAS NOTED THAT THE HCP WAS TO RESTART ORAL ANTIBIOTICS IF THERE WERE ANY ¿INCREASES¿ IN LAB WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192282 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 Required Intervention