MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR 3-4; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-2352-50

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Cerebrospinal Fluid Leakage (1772); Inadequate Pain Relief (2388)

Event Date 11/18/2021

Event Type  Injury  

Event Description

It was reported that the patient had a cerebrospinal fluid leak due to a non device related laminectomy procedure.The patient underwent a lead revision procedure wherein the physician tried to fix the lead placements but did it wrong.The patient underwent another lead revision procedure wherein the linear leads were replaced with paddle leads.The patient was doing well post operatively.The explanted leads were not returned.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2352700, model: sc-2352-70, serial: (b)(4), batch: 7073088/7072836/7073087.

• Brand Name: LINEAR 3-4
• 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: 13830916
• MDR Text Key: 287528395
• Report Number: 3006630150-2022-01127
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729789550
• UDI-Public: 08714729789550
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2023
• Device Model Number: SC-2352-50
• Device Catalogue Number: SC-2352-50
• Device Lot Number: 7074439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• 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): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female