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

Model Number 3186

Device Problems Failure to Deliver Energy (1211); No Apparent Adverse Event (3189)

Patient Problems Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2021

Event Type  Injury  

Manufacturer Narrative

Date of the event is estimated.

Event Description

Related manufacturer reference number: 3006705815-2023-00124 and 3006705815-2023-00126.It was reported the patient is not receiving effective therapy and the therapy strength is decreasing on its own due to high impedances.As such, surgical intervention was taken where a lead was explanted and replaced to address the issue.The investigation did not determine which lead had high impedances.

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.Patient had 2 leads implanted.One of the leads was replaced under related manufacturer reference number: 3006705815-2021-00126 and 3006705815-2021-00124.It is unknown which lead was replaced.Hence, all 3 leads are being reported.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16214232
• MDR Text Key: 307780913
• Report Number: 3006705815-2023-00125
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2022
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000103375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/26/2022
• Initial Date FDA Received: 01/20/2023
• Supplement Dates Manufacturer Received: 02/16/2023; 02/23/2023
• Supplement Dates FDA Received: 02/17/2023; 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCS ANCHOR (2); SCS IPG
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 79 KG