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

Model Number 3186

Device Problems Disconnection (1171); High impedance (1291); Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

¿date of event¿ is estimated.The results/ method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 3006705815-2020-31026.It was reported that the patient fell and experienced ineffective therapy.Diagnostic testing revealed high impedance on multiple contacts of one lead.Imaging showed that the lead migrated.Surgery may occur to address the issue.It is unknown which lead is related to the issue so all suspected leads are being reported.

Event Description

Additional information was received that the right-side lead had slightly migrated and the left-side lead had slightly come out of the ipg header.Surgery occurred on (b)(6) 2020 during which the left-side lead was reinserted into the ipg header to address the issue.It is unknown which lead is the right-side lead and which lead is the left-side lead.

Manufacturer Narrative

Corrections: b5: the previous report should have included the following information: related manufacturer reference number: 1627487-2020-32047 d11: the previous report should have included the following information: medical product: scs ipg therapy date: (b)(6) 2020.

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.

• 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: 10480840
• MDR Text Key: 205251980
• Report Number: 3006705815-2020-31025
• 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,Followup,Followup
• Report Date: 10/13/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2019
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000035060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 10/05/2020; 10/05/2020; 10/07/2020
• Supplement Dates FDA Received: 10/06/2020; 10/06/2020; 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD; SCS IPG; PERCUTANEOUS LEAD
• Patient Outcome(s): Other
• Patient Weight: 82