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

Model Number SC-2218-50

Device Problems Fracture (1260); High impedance (1291); Unexpected Therapeutic Results (1631)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

Exact date unknown, event occurred for a year and a half from the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: scs-linear leads.Upn: m365sc2218500.Model: sc-2218-50.Serial: (b)(4).Batch: 18915129.Product family: scs-linear leads.Upn: m365sc2218700.Model: sc-2218-70.Serial: (b)(4).Batch: 18437624/19164945.

Event Description

It was reported that the patient was not getting adequate pain relief.It was also reported that the patient had contacts out on the leads and appears that the anchors punched the leads.The patient underwent a lead replacement procedure.

Event Description

It was reported that the patient was not getting adequate pain relief.It was also reported that the patient had contacts out on the leads and appears that the anchors punched the leads.The patient underwent a lead replacement procedure.

Manufacturer Narrative

Sc-2218-50 (sn: (b)(6)).The returned leads were analyzed and the visual inspection revealed that all cables were completely broken at the bent or kinked location of the lead.The visual inspection found that the lead was exposed to excessive mechanical force or movement causing the cable fractures right at the anchor point.With all the available information, boston scientific concludes that the reported event was confirmed.Sc-2218-70 (sn: (b)(6)).The returned leads were analyzed and the visual inspection revealed that all cables were completely broken at the bent or kinked location of the lead.The visual inspection found that the lead was exposed to excessive mechanical force or movement causing the cable fractures right at the anchor point.With all the available information, boston scientific concludes that the reported event was confirmed.

• Brand Name: LINEAR ST
• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14950828
• MDR Text Key: 298511290
• Report Number: 3006630150-2022-03378
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: 08714729767725
• 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,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/22/2018
• Device Model Number: SC-2218-50
• Device Catalogue Number: SC-2218-50
• Device Lot Number: 18915129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2016
• 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: 52 YR
• Patient Sex: Male