MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD

Model Number 3186

Device Problems Fracture (1260); High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/29/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference number: 3006705815-2021-03893.It was reported that stimulation on the leads was reducing on its own.Both leads displayed high impedance.X-rays revealed potential fracture in one of the lead.Surgical intervention may take place to address the issue.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain weight but not received.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Additional information received indicated the patient underwent surgical intervention wherein both of the leads were explanted and replaced to address the issue.Therapy was restored postoperatively.

Manufacturer Narrative

The reported event of high impedances was confirmed.Both leads were returned complete.Microscopic inspection identified a kink in the lead body where all of the internal wires were broken followed by a cam impression mark.The fracture wires are consistent with overstress condition that leads may have been subjected to while in viv.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: PERCUTANEOUS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• MDR Report Key: 12341633
• MDR Text Key: 267238573
• Report Number: 3006705815-2021-03894
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2022
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000103987
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD; PERCUTANEOUS LEAD
• Patient Outcome(s): Other