MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE X 32; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-8352-50

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

Patient Problems Hematoma (1884); Muscle Weakness (1967); Paralysis (1997)

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

Report source other- (b)(6).

Event Description

It was reported that following a spinal cord stimulator lead trial, the patient stated he felt leg weakness throughout the five days of the trial, however, the trial was successful.Therefore, the patient underwent a permanent paddle lead implant procedure.While the patient was in pre-op for this implant procedure, and the following day, the patient stated he was unable to move his legs.A magnetic resonance imaging mri scan was taken and displayed thecal sac compression and an epidural hematoma at the thoracic vertebrae t12 through t9.The patient underwent an additional procedure the day after the implant procedure wherein the hematoma was removed.The device remains implanted in the patient.Post-operatively, the patient is recovering and has not yet gained back movement but has some returning sensation.The physician noted that recovery could take three to four weeks.The physician assessed the device in combination with the hematoma and some epidural narrowing contributed to the event.The patients symptoms were caused by the compression of the thecal sac due to the combination of the lead and the hematoma.

• Brand Name: COVEREDGE X 32
• 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: 13006780
• MDR Text Key: 282269157
• Report Number: 3006630150-2021-07091
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832683
• UDI-Public: 08714729832683
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/02/2022
• Device Model Number: SC-8352-50
• Device Catalogue Number: SC-8352-50
• Device Lot Number: 7001752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2017
• 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 Sex: Male