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

Model Number SC-2218-50

Device Problem Fracture (1260)

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

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: exact date unknown, event occured in (b)(6) 2021 based on the date the manufacturer became aware of the event.Sc-2218-50 (sn: (b)(4), the returned lead was analyzed, passed all tests performed, and exhibited normal device characteristics.Sc-4318 (batch/lot number: 26575414), the returned clik anchor was analyzed, passed all tests performed, and exhibited normal device characteristics.Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2218500, model: sc-2218-50, serial: (b)(4), batch: 7085396.Product family: scs-lead fixation, upn: m365sc43180, model: sc-4318, batch: 26575414.

Event Description

It was reported that patients leads and clik anchor were cut or damaged.The patient underwent an explant procedure.No further information has been obtained despite good faith efforts.

• 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; 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: 12388120
• MDR Text Key: 268879656
• Report Number: 3006630150-2021-04857
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2021

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: 11/13/2022
• Device Model Number: SC-2218-50
• Device Catalogue Number: SC-2218-50
• Device Lot Number: 7085338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2020
• 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: 59 YR