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

Model Number 3186

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).Date of event is estimated.

Event Description

It was reported the patient experienced ineffective stimulation.In turn, the lead was explanted and replaced to address the issue.Upon explant it was observed the lead had fractured.

Manufacturer Narrative

The reported event of high impedance was confirmed.Microscopic inspection of the return lead revealed a kink on the lead body with all internal wires were broken.The cause of the reported event is consistent with an overstress condition or sudden event the lead may have been subjected while in vivo.

• 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: 12344774
• MDR Text Key: 267344136
• Report Number: 3006705815-2021-04101
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2022
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000099313
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other