BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION MONTAGE

    MDR report key: 6603343 · Received May 31, 2017

    Report

    Report Number
    3006630150-2017-01988
    Event Type
    Death
    Date Received
    May 31, 2017
    Date of Event
    May 6, 2017
    Report Date
    May 6, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE COMPETITOR¿S PAIN PUMP WAS IMPLANTED ON (B)(6) 2015. ACCORDING TO THE PHYSICIAN, THE PAIN PUMP WAS STILL IN USE AT THE TIME OF THE EVENT AND DID NOT UNDERGO CURRENT/RECENT SERVICING. THE PHYSICIAN DOES NOT KNOW IF THE ABSCESS WAS AT THE SCS POCKET SITE OR THE PAIN PUMP POCKET SITE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-2408-56 SERIAL/LOT: (B)(4) DESCRIPTION: AVISTA MRI PERC LEAD KIT, 56 CM A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WAS FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A POCKET ABSCESS. THE PATIENT¿S SYMPTOMS WERE REPORTEDLY AN INFECTION, FEVER, INCISION SITE DRAINAGE AND ALTERED MENTAL STATUS. THE STAPHYLOCOCCUS AUREUS INFECTION WAS TREATED WITH IV ANTIBIOTICS (VANCOMYCIN, MEROPENEM, AND AMPHOTERICIN). ON (B)(6) 2017, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE ALL THE DEVICES AND A COMPETITORS PAIN PUMP WERE REMOVED. FOLLOWING THE EXPLANT PROCEDURE, THE PATIENT DEVELOPED SPINAL MENINGITIS THAT WENT INTRATHECAL AND THE PATIENT SUBSEQUENTLY PASSED AWAY ON (B)(6) 2017. THE PHYSICIAN INDICATED THAT THE PATIENT HAD COMORBIDITIES THAT MAY HAVE MADE HIM MORE VULNERABLE TO INFECTION. THERE MAY HAVE BEEN A SIGN OF WOUND INFECTION AT THE IMPLANT SITE, AND IT MAY HAVE BEEN DUE TO THE SCS IMPLANT PROCEDURE. THE PHYSICIAN ALSO STATED THAT THE INFECTION MAY BE RELATED TO THE INDWELLING PAIN PUMP OR TO ANY OTHER SPINAL INTERVENTION ADMINISTERED TO THE PATIENT. DEVICE MALFUNCTION WAS NOT SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A POCKET ABSCESS. THE PATIENT¿S SYMPTOMS WERE REPORTEDLY AN INFECTION, FEVER, INCISION SITE DRAINAGE AND ALTERED MENTAL STATUS. THE (B)(6) INFECTION WAS TREATED WITH IV ANTIBIOTICS (VANCOMYCIN, MEROPENEM, AND AMPHOTERICIN). ON (B)(6) 2017, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE ALL THE DEVICES AND A COMPETITORS PAIN PUMP WERE REMOVED. FOLLOWING THE EXPLANT PROCEDURE, THE PATIENT DEVELOPED SPINAL MENINGITIS THAT WENT INTRATHECAL AND THE PATIENT SUBSEQUENTLY PASSED AWAY ON (B)(6) 2017. THE PHYSICIAN INDICATED THAT THE PATIENT HAD COMORBIDITIES THAT MAY HAVE MADE HIM MORE VULNERABLE TO INFECTION. THERE MAY HAVE BEEN A SIGN OF WOUND INFECTION AT THE IMPLANT SITE, AND IT MAY HAVE BEEN DUE TO THE SCS IMPLANT PROCEDURE. THE PHYSICIAN ALSO STATED THAT THE INFECTION MAY BE RELATED TO THE INDWELLING PAIN PUMP OR TO ANY OTHER SPINAL INTERVENTION ADMINISTERED TO THE PATIENT. DEVICE MALFUNCTION WAS NOT SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382387 PRECISION MONTAGE SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 NA 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R