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 Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: (b)(4), model: sc-2352-70, serial: (b)(4), batch: 17411288.

Event Description

It was reported that the patient was experiencing inadequate therapy.A computed tomography (ct) myelogram was taken and revealed an abandoned electrode was present in the epidural space.The physician also confirmed that one of the leads was disconnected and broken which would not be a lead with changing or connecting to an mri compatible ipg.The lead remains implanted in the patient.

• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 10195164
• MDR Text Key: 197183304
• Report Number: 3006630150-2020-02626
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729789581
• UDI-Public: 08714729789581
• 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: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2016
• Device Model Number: SC-2352-70
• Device Catalogue Number: SC-2352-70
• Device Lot Number: 17411288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2014
• 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: 54 YR