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

Model Number 3186

Device Problems High impedance (1291); Insufficient Information (3190)

Patient Problems Inadequate Pain Relief (2388); No Information (3190)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

During processing of this incident, attempts were made to obtain complete event and device information.The results/ method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2020-48078.It was reported that the patient¿s scs system was explanted and replaced with a new scs system on (b)(6) 2020 for an unknown reason.

Event Description

Additional information received indicates that the ipg was not communicating with external device and was deemed inoperable.As such, surgical intervention took place to address the issue.During the, procedure high impedances were noted on the lead.As such, ipg and lead were explanted and replaced with a new scs system.Reportedly, therapy was confirmed post operatively.

Manufacturer Narrative

The allegation that stimulation could not be achieved was confirmed.The lead was returned cut in 3 pieces as a result of the explant procedure.Microscopic inspection identified a kink in the lead body where all the internal wires were broken.This would have caused the high impedance observed during the explant procedure before the lead was explanted.As there was no damage to the outer tubing and the lack of achievable therapy occurred prior to explant, the broken wires are consistent the lead being subjected to stress while in vivo.

Manufacturer Narrative

Additional information: device information was provided and is included in this submission as well as device return and evaluation status.Corrected data: d3 - manufacturer information, g1-2 manufacturing site name, d7 - date of explant manufacturer report number 1 was listed as '1627487', however this device was manufactured at the location with the registration number of (b)(4).

• 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: 10879983
• MDR Text Key: 217655124
• Report Number: 1627487-2020-48079
• Device Sequence Number: 1
• Product Code: LGW
• 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,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• 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 Lot Number: A000061793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS IPG, MODEL 3660
• Patient Outcome(s): Other