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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 Paralysis (1997); Urinary Retention (2119); Movement Disorder (4412); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/14/2021
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event. Product family scs-linear leads: upn: (b)(4). Model: sc-2316-50e. Serial:(b)(4). Batch: 7115359.
 
Event Description
It was reported that during a spinal cord stimulator implant procedure, the first lead was successfully placed on the left side, however difficulty was observed with percutaneous insertion of the lead on the right side. Although the recommended entry point for lead insertion is at t12 l1, the t10 t11 interlaminar space was selected as the entry point. Neurological monitoring indicated that the somatosensory evoked potentials and motors for the right side were no longer at baseline amplitudes. Both of the leads and needles were removed, and the patients back was opened up to determine if there was hemorrhaging. No clear cause was identified for the observed neurological symptoms, therefore the physician proceeded with inserting a single lead from the left side. After the procedure, the patient was admitted to the hospital for observation. It was reported that the patient was retaining urine several hours after the procedure and had also lost feeling in his legs. The lead was subsequently removed and magnetic resonance imaging revealed that the patients spinal cord was nipped, likely occurring during insertion of the second/right lead. The physician attributed the patients neurological symptoms to the presence of scar tissue from previous surgeries, contributing to the observed complications during this procedure. There were no physician-related allegations with the spinal cord stimulator or the associated leads. Based on the available information, the patient is expected to make a full recovery.
 
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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 Key11286633
MDR Text Key230510667
Report Number3006630150-2021-00314
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030017
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 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSC-2316-50E
Device Catalogue NumberSC-2316-50E
Device Lot Number7114651
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 Received01/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/20/2020
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: 02/05/2021 Patient Sequence Number: 1
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