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

Model Number 3186

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Erosion (2075)

Event Date 06/09/2020

Event Type  Injury  

Event Description

Related manufacturer reference number: 3006705815-2020-02381.It was reported the patient's lead was eroding through.Surgical intervention on (b)(6) 2020 found no erosion but there was a lead loop pushing up under the patients skin at the insertion site.Physician was able to bury the loop deeper and anchor it place to address the issue.

Event Description

Additional information indicates the system was explanted.

Manufacturer Narrative

Correction: section h6 - method code should have been 4117 rather than 4114.

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: 10176799
• MDR Text Key: 195946355
• Report Number: 3006705815-2020-02380
• 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: 08/11/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2021
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000079774
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 07/08/2020; 07/15/2020; 08/09/2020
• Supplement Dates FDA Received: 07/10/2020; 07/30/2020; 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL # 3186 - LEAD.; MODEL # 3186 - LEAD
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 73