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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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BOSTON SCIENTIFIC NEUROMODULATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE Back to Search Results
Model Number 101-9812
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Apnea (1720); Cardiac Arrest (1762); No Code Available (3191)
Event Date 07/01/2020
Event Type  Injury  
Event Description
It was reported that the patient, that is a participant in the scope clinical trial, had a cardiac arrest during the implant procedure which was determined to be related to the anesthesia.The patient was hospitalized and acls, advanced cardiac life support, protocol was followed.This event was reported as not being related to the device or disease progression and assessed as probably being related to the procedure.The device remains implanted.The patient current status is unknown.
 
Event Description
It was reported that the patient, that is a participant in the scope clinical trial, had a cardiac arrest during the implant procedure which was determined to be related to the anesthesia.The patient was hospitalized and acls, advanced cardiac life support, protocol was followed.This event was reported as not being related to the device or disease progression and assessed as probably being related to the procedure.The device remains implanted.The patient current status is unknown.Additional information was received that after completion of the surgical placement of ids, indirect decompression system, at the outpatient surgery center, the patient stopped breathing and turned blue.Cpr, cardiopulmonary resuscitation, was performed and pulse was attained during the first round of cpr attempt.The patient then presented to the emergency room where he was hospitalized for further evaluation.Blood work, computerized tomography scan, x-ray and electrocardiography were performed with no significant findings except for low lung volume on x-ray and intermittent atrial flutter with occasional bursts of atrial fibrillation on ecg.The patient was given medication.Cardiac catheterization was performed on which resulted in stent placement on four days later.The subject tolerated the procedure well.The patient was discharged and the event is resolved.The events relationship to the procedure was assessed as probable.The patient voluntarily withdrew from the study.
 
Event Description
It was reported that the patient, that is a participant in the (b)(6) clinical study had a cardiac arrest during the implant procedure which was determined to be related to the anesthesia.The patient was hospitalized and acls, advanced cardiac life support, protocol was followed.This event was reported as not being related to the device or disease progression and assessed as probably being related to the procedure.The device remains implanted.The patient current status is unknown.Additional information was received that after completion of the surgical placement of ids, indirect decompression system, at the outpatient surgery center, the patient stopped breathing and turned blue.Cpr, cardiopulmonary resuscitation, was performed and pulse was attained during the first round of cpr attempt.The patient then presented to the emergency room where he was hospitalized for further evaluation.Blood work, computerized tomography scan, x-ray and electrocardiography were performed with no significant findings except for low lung volume on x-ray and intermittent atrial flutter with occasional bursts of atrial fibrillation on ecg.The patient was given medication.Cardiac catheterization was performed on which resulted in stent placement on four days later.The subject tolerated the procedure well.The patient was discharged and the event is resolved.The events relationship to the procedure was assessed as probable.The patient voluntarily withdrew from the study.Additional information was received that the event was assessed by boston scientific neuromodulation as probably related to the procedure.
 
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Brand Name
SUPERION INDIRECT DECOMPRESSION SYSTEM
Type of Device
PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
suite 100
valencia CA 91355
MDR Report Key10486330
MDR Text Key205456911
Report Number3006630150-2020-03886
Device Sequence Number1
Product Code NQO
UDI-Device Identifier00884662000543
UDI-Public00884662000543
Combination Product (y/n)N
PMA/PMN Number
P140004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number101-9812
Device Catalogue Number101-9812
Device Lot Number800235
Was Device Available for Evaluation? No
Date Manufacturer Received09/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age73 YR
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