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

Model Number SC-2352-70

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631); Positioning Problem (3009)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/18/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: scs-extension, upn: m365sc3138350, model: sc-3138-35, serial: (b)(4), batch: 7072776.

Event Description

It was reported that the patients lead exhibited high impedances on contact 2.The lead was implanted epidural in the cervical area.The physician noted that they had difficulty advancing the lead due to some stenoses in the spinal canal.The patient later refused this form of the therapy for himself and all implanted products were explanted.All explanted products were disposed by the operating room nurse.The patient is doing well postoperatively.

• 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: 12929986
• MDR Text Key: 281741338
• Report Number: 3006630150-2021-06927
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729789581
• UDI-Public: 08714729789581
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/18/2023
• Device Model Number: SC-2352-70
• Device Catalogue Number: SC-2352-70
• Device Lot Number: 7072581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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: 33 YR