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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 Atrial Fibrillation (1729); Muscle Spasm(s) (1966); Nausea (1970); Respiratory Distress (2045); Anxiety (2328); Discomfort (2330); No Code Available (3191)
Event Date 02/10/2020
Event Type  Injury  
Manufacturer Narrative

Model number/ catalog number: sc-2316-50e, serial number: (b)(4), batch/ lot number: 5124909, model/ catalog description: infinion 16 trial lead kit 50 cm. The explanted devices were not returned to bsn as there were discarded by the medical facility.

 
Event Description

A report was received that following a trial procedure the patient was experiencing spasms, nausea, and anxiousness. The patient was given intravenous valium and had respiratory distress post valium, heart rate in atrial fibrillation. Due to the atrial fibrillation, the need for blood thinners and an increase in anxiety, a decision was made to pull leads and abort trial so other health issues unrelated to stim could be addressed. The patient was doing well postoperatively.

 
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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 Key9778341
MDR Text Key181740404
Report Number3006630150-2020-00922
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 03/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/07/2021
Device MODEL NumberSC-2316-50E
Device Catalogue NumberSC-2316-50E
Device LOT Number5116537
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 Received02/11/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/09/2019
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: 03/03/2020 Patient Sequence Number: 1
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