BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4003636 · Received August 12, 2014

    Report

    Report Number
    3004209178-2014-15180
    Event Type
    Injury
    Date Received
    August 12, 2014
    Report Date
    July 18, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97740, SERIAL# B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7495-51, SERIAL# B)(4), IMPLANTED: B)(6) 1996, PRODUCT TYPE: EXTENSION. PRODUCT ID: 74001, LOT# N231657, IMPLANTED: B)(6) 2012, PRODUCT TYPE: ADAPTER. PRODUCT ID: 3888-28, LOT# L40907, IMPLANTED: B)(6) 1996, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-29, LOT# N350850, IMPLANTED: B)(6) 2014, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT SITE WAS SENSITIVE, EXTREMELY ITCHY, AND TENDER SINCE HAVING THE IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTED. IT WAS NOTED THAT THE PATIENT¿S HEALTHCARE PROVIDER (HCP) HAD SAID THAT THE EVENT COULD BE RELATED TO THE ADHESIVE TAPE THAT MAY HAVE BEEN USED. IT WAS NOTED THAT THIS WAS THE PATIENT¿S 10TH DEVICE, AND THE PATIENT HAD NEVER HAD ANY ISSUES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO PRODUCT ISSUES. IT WAS STATED THAT THE DEVICE WAS EXPLANTED DUE TO A ¿LATE INFECTION AT THE POCKET SITE.¿ IT WAS NOTED THAT NO CULTURES HAD BEEN TAKEN. IT WAS FURTHER NOTED THAT THE INFECTION HAD ONSET ¿5-6 DAYS AGO.¿ IT WAS STATED THAT THERE WAS PAIN AND REDNESS AT THE DEVICE POCKET AND THE EXTENSION LOCATION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S INS AND EXTENSION WERE EXPLANTED ON THE NIGHT OF (B)(6) 2014. IT WAS STATED THAT THE PATIENT WOULD BE UNDERGOING ANTIBIOTIC THERAPY FOR APPROXIMATELY 6 WEEKS AND WOULD THEN BE RE-IMPLANTED WITH A NEW EXTENSION AND INS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INFECTION WAS LIMITED TO THE POCKET AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477741 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention