MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR 3-4; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-2352-50

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paralysis (1997)

Event Date 03/29/2021

Event Type  Injury  

Event Description

It was reported that following a spinal cord stimulator (scs) implant procedure, the patient had no motor movement of the lower right proximity.The physician assessed that the event was not device related and was possibly due to nerve root irritation.The patient has been moved to a rehabilitation center.

• 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; 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: 11691261
• MDR Text Key: 246228626
• Report Number: 3006630150-2021-01662
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729789550
• UDI-Public: 08714729789550
• 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: 04/19/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/21/2022
• Device Model Number: SC-2352-50
• Device Catalogue Number: SC-2352-50
• Device Lot Number: 5015861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2018
• 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: 74 YR