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

Model Number 3186

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

Patient Problem Sepsis (2067)

Event Date 03/18/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with the investigation results will be provided in the final report.

Event Description

Device 1 of 4.Reference mfr.Report#: 3006705815-2020-01642.Reference mfr.Report#: 1627487-2020-03883.Reference mfr.Report#: 1627487-2020-03884.It was reported the patient was admitted to the hospital and sepsis was determined to be the issue that was alleged to be related to the patient's lead incision.The patient's current status is unknown at this time.

Event Description

Device 1 of 4.Reference mfr.Report#: 3006705815-2020-01642.Reference mfr.Report#: 1627487-2020-03883.Reference mfr.Report#: 1627487-2020-03884.Follow-up revealed the patient's issue resolved over time.

Event Description

Device 1 of 4 reference mfr.Report#: 3006705815-2020-01642, reference mfr.Report#: 1627487-2020-03883, reference mfr.Report#: 1627487-2020-03884.

Manufacturer Narrative

A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: SCS 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: 9955466
• MDR Text Key: 187506349
• Report Number: 3006705815-2020-01641
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2021
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000082109
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL: 1192 (X2), SCS ANCHORS; MODEL: 3186, SCS LEAD
• Patient Outcome(s): Hospitalization
• Patient Weight: 104