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

Model Number 3186

Device Problem High impedance (1291)

Patient Problem Failure of Implant (1924)

Event Date 07/12/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference number: 3006705815-2021-03844.It was reported that the patient's system cannot be placed into mri mode.Diagnostic revealed high impedances on several contacts.As a result, surgical intervention may be pending to address this issue at a later date.It is unknown which lead has high impedances, therefore both leads are being reported.

Manufacturer Narrative

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 stated that the patient underwent surgical intervention wherein the leads were explanted and replaced with a penta paddle lead.Post-operatively, stimulation therapy was restored and the system was able to go into mri mode.

• 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: 12287871
• MDR Text Key: 265388659
• Report Number: 3006705815-2021-03845
• 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
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2023
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000104548
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD; PERCUTANEOUS LEAD
• Patient Outcome(s): Other
• Patient Weight: 79