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

Model Number SC-8336-50

Device Problems Unexpected Therapeutic Results (1631); Low impedance (2285)

Patient Problem Pain (1994)

Event Date 09/29/2023

Event Type  Injury  

Event Description

It was reported that the spinal cord stimulation (scs) patient underwent a revision procedure to reposition the paddle lead.The reason for the revision was unknown but was likely related to stimulation coverage.It was noted that the paddle lead had to be cleaned since there was white debris on the lead contacts, which caused reduced impedances.A plasma blade was also used sparingly at the site of the paddle lead.The implantable pulse generator (ipg) pocket was not opened or touched during the procedure.The patient was doing well postoperatively and has had no device issues after being reprogrammed.

Event Description

It was reported that the spinal cord stimulation (scs) patient underwent a revision procedure to reposition the paddle lead.The reason for the revision was unknown but was likely related to coverage.It was noted that the paddle lead had to be cleaned since the lead contacts were being impacted and causing reduced impedances.A plasma blade was used sparingly at the site of the paddle.The implantable pulse generator (ipg) pocket was not opened or touched during the procedure.The patient was doing well postoperatively and has had no device issues after being reprogrammed.

• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 18085478
• MDR Text Key: 327546246
• Report Number: 3006630150-2023-06835
• Device Sequence Number: 1
• Product Code: LGW
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/03/2017
• Device Model Number: SC-8336-50
• Device Catalogue Number: SC-8336-50
• Device Lot Number: 17939612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• 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