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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2316-50E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Respiratory Distress (2045); Weakness (2145); No Code Available (3191)
Event Date 04/14/2020
Event Type  Injury  
Event Description

It was reported that after the implant of the lumbar trial for spinal cord stimulator, the patient had labored breathing laying prone and sitting up. It was also stated that the patient had weakness in the four extremities due to anesthesia. The patient was given 30 mcg of epinephrine along with 50mg of benadryl and 10mg of decadron. The patient was also given a nebulizer breathing treatment and was given 100 percent positive oxygen. It was determined that the patient had a high spinal anesthetic and had no rectal sphincter tone. The patient was given 100 percent oxygen which was 4ml pf 0. 25 percent bupivacaine at one puff. The patient was then admitted to the hospital. The next day, the patients hemodynamics were then stable and was able to move the four extremities without difficulty.

 
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Brand NameINFINION 16
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
road 698, lot no. 12
dorado PR 00646 -260
00646-2602
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key10681395
MDR Text Key211423198
Report Number3006630150-2020-04874
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberSC-2316-50E
Device Catalogue NumberSC-2316-50E
Device LOT Number7087954
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/24/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/14/2020 Patient Sequence Number: 1
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