BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2920112 · Received January 17, 2013

    Report

    Report Number
    3004209178-2013-00705
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 28, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE CAUSE OF THE EVENT WAS WOUND INFECTION. LEAD WIRES WERE REMOVED DUE TO THE INFECTION AND REPLACED AT A LATER TIME ON (B)(6) 2012 WITH A PADDLE ELECTRODE CONNECTED TO EXISTING IMPLANTABLE NEUROSTIMULATOR (INS) IN RIGHT UPPER BUTTOCK. REPROGRAMMING WAS PERFORMED ON (B)(6) 2013 DURING POST OP EVALUATION WITH ADEQUATE STIMULATION THERAPY. THE PATIENT REQUIRED NO HOSPITALIZATION AND NO PATIENT INJURY WAS STATED. IT WAS ALSO REPORTED THAT AFTER THE INS IMPLANT THE PATIENT SUBSEQUENTLY DEVELOPED A WOUND INFECTION OVERLYING THE DEVICE AND LEAD WIRE THAT HAD PREVIOUSLY BEEN IMPLANTED "WHILE LEAVING THE NEW INS IN PLACE IN RIGHT UPPER BUTTOCK." IN ADDITION, IT WAS ALSO REPORTED THAT THE DATE OF ONSET/DIAGNOSIS OF INFECTION WAS (B)(6) 2012. IT WAS UNKNOWN IF PERIOPERATIVE ANTIBIOTICS HAD BEEN ADMINISTERED. NO MENINGITIS WAS REPORTED. SIGNS/SYMPTOMS WERE REDNESS, SWELLING, DRAINAGE AT THE LEAD TRACK. THE CULTURE WAS OBTAINED IN DEVICE POCKET, LUMBAR REGION. TREATMENT FOR INFECTION INCLUDED PARTIAL SYSTEM EXPLANT. PATIENT OUTCOME WAS REPORTED AS "INFECTION RESOLVED."

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN INFECTION. THE PATIENT HAD A REPLACEMENT OF THEIR DEVICE AND GOT A SURGICAL INFECTION RESULTING IN THREE SURGERIES AND THE PATIENT HAVING THEIR LEADS REMOVED IN (B)(6) 2012. IT WAS NOTED THE PATIENT HAD THE INS PUT IN (B)(6) 2012 AND WAS GIVEN A RECHARGER TO KEEP DEVICE CHARGED. THE LEADS WERE REPLACED (B)(6) 2012. IT WAS NOTED THE PATIENT NEVER RECEIVED A RECHARGER WITH THEIR INS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26445 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