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

Model Number SC-2218-70

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Undesired Nerve Stimulation (1980); Burning Sensation (2146); Inadequate Pain Relief (2388)

Event Date 12/28/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced a sharp burning sensation and discomfort around the lead site when stimulation was turned on.It was also reported that the patient experienced inadequate stimulation.It was further noted that the patient was involved in a non device related auto collision.The patient underwent a lead replacement procedure and was doing well post-operatively.The explanted lead 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; 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: 12195145
• MDR Text Key: 262401676
• Report Number: 3006630150-2021-03899
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/06/2020
• Device Model Number: SC-2218-70
• Device Catalogue Number: SC-2218-70
• Device Lot Number: 5024810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2018
• 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: 49 YR