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

Model Number SC-8336-50

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

Patient Problems Paralysis (1997); No Code Available (3191)

Event Date 08/05/2020

Event Type  Injury  

Event Description

It was reported that after the permanent implant, the patient had no feeling in the legs or groin.The patient was taken back into the operating room and underwent a revision procedure wherein the lead was pulled out of the spinal canal and epidural space to reduce possible compression on the spinal cord, the device remains implanted.The patient regained feeling in the legs the next day but was still not able to walk.No device malfunction was suspected.The physician believed that the spinal cord injury was due to surgical complications.The patient was sent to a rehabilitation facility to do physical therapy to regain function.The patient is doing well and slowly regaining function of the extremities.The physician is hopeful that he will be able to reposition the paddle lead in several weeks.

• Brand Name: COVEREDGE 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; RQ 00646-2602
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 10457665
• MDR Text Key: 204552922
• Report Number: 3006630150-2020-03699
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832669
• UDI-Public: 08714729832669
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/20/2022
• Device Model Number: SC-8336-50
• Device Catalogue Number: SC-8336-50
• Device Lot Number: 7071543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2020
• 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: 53 YR