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

Model Number SC-8336-50

Device Problems Fracture (1260); Unexpected Therapeutic Results (1631); Migration (4003)

Patient Problems Inadequate Pain Relief (2388); Implant Pain (4561)

Event Date 07/06/2021

Event Type  malfunction  

Manufacturer Narrative

Exact date unknown, event occurred two weeks after the date of implant.Additional suspect medical device component involved in the event: product family: scs-ipg-r-mri upn: m365sc12320.Model: sc-1232.Serial: (b)(4).Batch: 512936.

Event Description

It was reported that the patient was experiencing pain at the lead site, inadequate stimulation and loss of stimulation due to lead migration.X-ray was taken and showed that the paddle lead had ripped into two and was completely out of epidural space.It was also noted that the ends of the wires pulled out of the ipg.The patient had a non-device related hard fall after the implant surgery.Reprogramming was attempted, however, unsuccessful.The patient underwent a revision procedure wherein the paddle lead and ipg were replaced.The patient was doing well post-operatively and the explanted devices were discarded.

• 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; * 00646-2602
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12356127
• MDR Text Key: 267757493
• Report Number: 3006630150-2021-04707
• 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: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/29/2022
• Device Model Number: SC-8336-50
• Device Catalogue Number: SC-8336-50
• Device Lot Number: 7072046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2020
• 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: 54 YR