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

Model Number SC-8352-70

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

Patient Problems Hematoma (1884); Paralysis (1997)

Event Date 04/07/2022

Event Type  Injury  

Event Description

It was reported that the morning following a spinal cord stimulator paddle lead implant procedure, the patient experienced bilateral lower extremity paralysis yet had some feeling in the legs.A magnetic resonance image mri was needed, however, the device needed to be explanted prior to imaging per the instructions for use, ifu.The physician assessed it would be safest to remove the paddle lead in case there was swelling or fluid accumulation in the epidural space causing compression of the spinal cord.Therefore, the patient underwent a system explant procedure and obtained the mri.The post-explant mri displayed an epidural hematoma from the t6 to the t11 vertebrae.The patient was intubated and on a ventilator.There were plans to extubate the patient and place on palliative care, however, no further information has been obtained regarding the patient status despite three good faith effort attempts.The lead was easily inserted during the implant procedure and there were no procedural complications noted at time of implant nor explant.The paddle lead will not be returned as it was retained by the medical facility.

• 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: 14247353
• MDR Text Key: 290388015
• Report Number: 3006630150-2022-01919
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832690
• UDI-Public: 08714729832690
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2022
• Device Model Number: SC-8352-70
• Device Catalogue Number: SC-8352-70
• Device Lot Number: 7070111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2020
• 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): Hospitalization; Other; Required Intervention
• Patient Sex: Male