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

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.

• Brand Name: INFINION 16
• Type of Device: STIMULATOR, 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 Key: 11286633
• MDR Text Key: 230510667
• Report Number: 3006630150-2021-00314
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797807
• UDI-Public: 08714729797807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/20/2022
• Device Model Number: SC-2316-50E
• Device Catalogue Number: SC-2316-50E
• Device Lot Number: 7114651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR