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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 Chest Pain (1776); Emotional Changes (1831); Hemorrhage/Bleeding (1888); Neck Pain (2433)
Event Date 02/26/2021
Event Type  Injury  
Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event. Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: (b)(4), model: sc-2316-50e, serial: (b)(4), batch: 7113842.

 
Event Description

It was reported that after the lead pull procedure, the patient had severe pain at the neck, back and chest. The patient was sent for a magnetic resonance imaging (mri), but the patient refused and was non-compliant. The patient was taken to the emergency room wherein it was determined that there was no problem suspected at first and the physician believed that the patient was having manic episode. It was also then reported that the patient had an epidural bleed which was unclear if it was related to the lead pull procedure. The patient was put into the hospital for observation. The removed leads were discarded.

 
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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 Key11690993
MDR Text Key246214442
Report Number3006630150-2021-01652
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 04/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/19/2021
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 Number7109069
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 Received03/28/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/23/2020
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: 04/19/2021 Patient Sequence Number: 1
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