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

Model Number 3186

Device Problems Disconnection (1171); High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient lost therapy due to high impedance.In turn, surgical intervention took place on (b)(6) 2020 wherein impedance check was performed on the lead.Diagnostics revealed high impedances.X-rays revealed that the lead seemed to have shifted slightly from the ipg header.As such, additional surgical intervention may take place at a later date to address the issue.

Event Description

Additional information received indicates that surgical intervention took place on (b)(6) 2020 wherein the lead was explanted and replaced with new lead to address the issue, reportedly, therapy was resumed post operatively.

Manufacturer Narrative

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

Event Description

During the procedure, the physician did not confirm that the lead shifted from the ipg header.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: SCS 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: 10125720
• MDR Text Key: 194301011
• Report Number: 3006705815-2020-02133
• 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,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2020
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000061793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other