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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEURO SPINAL STIMULATOR: PRECISION: CHARGING SYSTEM MODEL # SC-6412-3, REMOTE CO STIMULATOR SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC CORPORATION NEURO SPINAL STIMULATOR: PRECISION: CHARGING SYSTEM MODEL # SC-6412-3, REMOTE CO STIMULATOR SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Loss of consciousness (2418)
Event Date 10/07/2016
Event Type  Death  
Event Description
On (b)(6) 2016, my husband, (b)(6) underwent a surgical procedure to implant the boston scientific neuro spinal stimulator at (b)(6) hospital, (b)(6). The procedure was performed on an outpatient basis. On (b)(6) 2016, he died at home. At approximately 2 pm, he suddenly lost consciousness. The emt for (b)(6) arrived at approximately 2:20pm. He was pronounced dead at 2:47pm. The emt staff were informed that my husband had the implant procedure approximately 24 hours earlier. They did not return my husband to (b)(6), despite my repeated requests to return him for an autopsy. I was informed that it was my responsibility to contact the medical examiner's office, (b)(6). The county police also informed me that they could not assist or facilitate an autopsy. The device remains in my husband's body. I have all material(s) given to us at the hospital. Note: no discharge instructions were provided by the boston scientific representative, (b)(4).
 
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Brand NameNEURO SPINAL STIMULATOR: PRECISION: CHARGING SYSTEM MODEL # SC-6412-3, REMOTE CO
Type of DeviceSTIMULATOR SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key8405490
MDR Text Key138356939
Report NumberMW5084761
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 03/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2019
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/08/2019 Patient Sequence Number: 1
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