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 Difficult to Insert (1316); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: scs-lead fixation, upn: (b)(4), model: sc-4318, serial: na, batch: 25906221.

Event Description

It was reported that after a permanent trial, the patient underwent a permanent ipg implant procedure.During the implant procedure, the patient's lead was bent at the connector due to an unknown reason and could not be inserted into the ipg.The lead and clik anchor were explanted and replaced.The patient was doing well postoperatively.

Manufacturer Narrative

With the available information, boston scientific concluded through laboratory analysis that the event of the lead being bent was confirmed.The lead sc-2352-70, sn (b)(6) was analyzed and revealed that the proximal contact # 7 was kinked/deformed.The contact deformation resulted in the inability to fully insert the lead proximal contacts into the ipg port.This type of damage is typically caused by the use of a surgical tool.It appears that the lead contact was damaged during the procedure.Based on objective evidence from the field and testing of the returned device, engineers concluded that unintended use error caused or contributed to the event of the lead being bent.A labelling review was performed for the lead sc-2352-70, sn (b)(6) and it did not reveal any anomalies.The ifu states: avoid damaging the lead with sharp instruments or excessive force during surgery.Do not sharply bend or kink the lead, extension or splitter.The clik x anchor sc-4318, lot: 25906221 was returned and analyzed.External visual inspection revealed no anomalies.The clik x anchor exhibited normal device characteristics and laboratory analysis of the returned device did not identify any product performance-related issues.A labelling review was performed for the clik x anchor sc-4318, lot: 25906221.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/ifu.

Event Description

It was reported that after a permanent trial, the patient underwent a permanent ipg implant procedure.During the implant procedure, the patients lead was bent at the connector due to an unknown reason and could not be inserted into the ipg.The lead and clik anchor were explanted and replaced.The patient was 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
• MDR Report Key: 11530662
• MDR Text Key: 241103384
• Report Number: 3006630150-2021-01102
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729789581
• UDI-Public: 08714729789581
• Combination Product (y/n): N
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2022
• Device Model Number: SC-2352-70
• Device Catalogue Number: SC-2352-70
• Device Lot Number: 7071127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2021
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention