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 Problems Abscess (1690); Unspecified Infection (1930)

Event Date 07/13/2020

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.During processing of this complaint, attempts were made to obtain complete patient information.

Event Description

Related manufacturer report number: 3006705815-2020-30398, 1627487-2020-23251, 1627487-2020-23252.It was reported that the patient had an infection and an abscess that ruptured near the lead site.As a result, the patient underwent surgical intervention during which the system was explanted.

Manufacturer Narrative

The reported adverse event is not able to be confirmed with product testing.As received, the lead was complete but cut.The lead was returned cut as a result of the explant procedure.Microscopic inspection of the lead segments did not identify any fractures.Functional testing of the terminal and stimulation segments were performed by measuring continuity between the contacts and the end of the corresponding cut wires.Continuity of the lead body segment was measured from end to end of each wire.No opens were observed in any of the lead segments.A packaging and sterility review of the production records found no non-conformance's.

Event Description

Additional information received indicates that the infection had later cleared.

• 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: 10354104
• MDR Text Key: 201343231
• Report Number: 3006705815-2020-30397
• 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
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2022
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000096441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS LEAD; SCS LEAD ANCHOR (X2)
• Patient Outcome(s): Other