BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3241361 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12119
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 377875, LOT# V007655, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 377875, LOT# V007655, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HCP PLANNED TO REPLACE THE PERCUTANEOUS LEADS WITH A NEW PADDLE LEAD. WHEN THE IPG POCKET WAS OPENED THERE WAS SOME REDNESS, SWELLING AND SOME PUS. A DECISION WAS MADE TO EXPLANT THE FULL SYSTEM AND TREATTHE INFECTION AS NECESSARY. A SUSPECTED INFECTION WAS REPORTED AND IT WAS REPORTED THAT A CULTURE WAS TAKEN FROM THE DEVICE POCKET.IT WAS REPORTED THAT THE PATIENT WOULD BE TREATED FOR INFECTION AND WOULD BE RE-IMPLANTED AS A FUTURE DATE. IT WAS REPORTED THAT THERE WERE NO PATIENT SYMPTOMS / INJURIES RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED AT THE PATIENT'S FIRST VISIT THE AREA AROUND THE GENERATOR DID NOT APPEAR RIGHT. THE PATIENT PRESENTED WITH REDNESS. THE PRIMARY LOCATION OF THE INFECTION WAS THE DEVICE POCKET AND A CULTURE WAS OBTAINED. THE ORGANISM CULTURED WAS (B)(6). THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND THE INFECTION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341224 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 00059 YR Required Intervention