BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3214185 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11512
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 17, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 97714, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD AN INFECTION AT THE DEVICE POCKET. IT WAS NOTED THE PATIENT HAD REDNESS AND DRAINAGE. IT WAS FURTHER NOTED THE PATIENT WAS GIVEN PERIOPERATIVEANTIBIOTICS. IT WAS NOTED THE PATIENT DID NOT HAVE MENINGITIS. IT WAS FURTHER NOTED THAT A CULTURE WAS OBTAINED FROM THE PATIENT¿S DEVICE POCKET AND LUMBAR REGION AND THE TYPE OF ORGANISM CULTURED WAS (B)(6). IT WAS NOTED THE PATIENT WAS GIVEN IV AND ORAL ANTIBIOTICS. IT WAS FURTHER NOTED THE INFECTION HAD RESOLVED. THE REPORTER STATED THE PATIENT HAD A PREVIOUS HISTORY OF WOUND INFECTIONS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED PREOPERATIVE ANTIBIOTICS WERE ADMINISTERED AND THE SIGNS AND SYMPTOMS OF INFECTION INCLUDED REDNESS. IT WAS STATED TREATMENTS INSTITUTED FOR INFECTION INCLUDED IV ANTIBIOTICS AND ORAL ANTIBIOTICS AND THE ENTIRE SYSTEM WAS EXPLANTED. IT WAS ALSO STATED THE INFECTION RESOLVED, BUT THE PATIENT OUTCOME WAS ONGOING. REPORTEDLY, THE PATIENT WAS ¿WITHOUT MIRSA.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE POCKET AND LEAD INCISION INFECTIONS. A CULTURE WAS TAKEN FROM THE DEVICE POCKET, BUT THE TYPE OF INFECTION WAS UNKNOWN. IT WAS NOTED THAT THE LOCATION OF THE SYMPTOMS WAS THE DEVICE POCKET AND LEAD LOCATION. SYMPTOMS INCLUDED DRAINAGE, INCISIONAL WOULD OPENING AND REDNESS. THE DEVICE WAS EXPLANTED AND THE WOUNDS WERE CLOSED. PATIENT STATUS WAS REPORTED AS ALIVE WITH INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS HAVING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED TODAY DUE TO INFECTION. IT WAS NOTE THE MANUFACTURING REPRESENTATIVE WAS NOTIFIED OF THE INFECTION LAST WEEK. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD THEIR ENTIRE SYSTEM REMOVED DUE TO INFECTION ABOUT 2 MONTHS AGO. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312453 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 00053 YR Required Intervention