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

Model Number SC-2218-70

Device Problems Fracture (1260); Difficult to Remove (1528); Unexpected Therapeutic Results (1631); Use of Device Problem (1670)

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

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.

Event Description

It was reported that the patient was experiencing inadequate stimulation due to lead fracture.The patient underwent a revision procedure wherein, the ipg and one lead were explanted but part of the one lead was left in place as physician could not get the other lead due to excessive scar tissue.The explanted devices will not be returned.

• 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: 11439569
• MDR Text Key: 238855529
• Report Number: 3006630150-2021-00824
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767749
• UDI-Public: 08714729767749
• 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: 03/08/2021

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: 09/01/2014
• Device Model Number: SC-2218-70
• Device Catalogue Number: SC-2218-70
• Device Lot Number: 15502294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 03/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2012
• 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: 38 YR