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

Model Number 3186

Device Problem High impedance (1291)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Date 03/11/2024

Event Type  Injury  

Event Description

It was reported that patient experienced ineffective therapy.Lead diagnostics showed that contacts 9-16 had high impedances.Reprogramming was attempted to no avail.Surgical intervention may be undertaken to address this issue.

Manufacturer Narrative

Section b3: date of event is estimated.The allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: scs octrode lead, model: 3186, udi: (b)(4), serial: (b)(6), batch: a000136285.

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 indicated that surgical intervention was undertaken wherein the lead was explanted and replaced.Effective therapy was restored.

Manufacturer Narrative

Section d4 - serial number, lot number, expiration date corrected.Section h4 - device manufacture date corrected.The allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: scs octrode lead, model: 3186, udi: (b)(4), serial: (b)(6), batch: a000136285.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: SCS 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18992007
• MDR Text Key: 338806652
• Report Number: 3006705815-2024-02323
• 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: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3186
• Device Lot Number: A000136226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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 (1); SCS PERCUTANEOUS LEAD (1)
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 79 KG