MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 90CM LENGTH; SCS LEAD

Model Number 3189

Device Problems High impedance (1291); Material Twisted/Bent (2981)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported the patient experienced a loss of stimulation.Diagnostics revealed high impedances of the patient¿s lead, and reprogramming was unable to resolve the issue.To address the issue, the physician performed a revision on (b)(6) 2020 where it was discovered there was a kink in the lead at the anchor site.The physician explanted the lead and implanted a new one, which resolved the issue.

Manufacturer Narrative

A case of high impedance due to lead damage was reported to abbott.During revision, the physician noted that the lead was kinked around the anchor.The lead was replaced to reestablish effective therapy.No implants were returned for evaluation/disposal.As a result, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances noted that could have contributed to this issue.Based on the information received, a single definitive root cause for the reported issue was unable to be conclusively determined, however the lead damage is consistent with an over stress situation in-vivo.

• Brand Name: OCTRODE LEAD KIT, 90CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9965748
• MDR Text Key: 187846276
• Report Number: 1627487-2020-03870
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401715
• UDI-Public: 05414734401715
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2019
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 6174511
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other