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

Model Number 3086

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

Patient Problem Abscess (1690)

Event Date 04/15/2019

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 2 of 2, mfg report reference: 3006705815-2019-01497.It was reported that the patient experienced an abscess.The patient had a successful trial, however upon the trial removal the patient reported sweating, chills and redness present under the bandage.It was later reported that the patient went to the hospital on (b)(6) 2019 and was diagnosed with an abscess.

Event Description

Mfg report reference: 3006705815-2019-01497.Follow up information received that the issue has been resolved.

Event Description

Device 2 of 2, mfg report reference: 3006705815-2019-01497.Follow up information received regarding additional patient information.It was also reported that the patient was getting the abscess evacuated.

• Brand Name: OCTRODE TRIAL 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
• 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8544422
• MDR Text Key: 142905403
• Report Number: 3006705815-2019-01498
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401555
• UDI-Public: 05414734401555
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2021
• Device Model Number: 3086
• Device Lot Number: A000076407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2019
• 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: MODEL 3086, SCS LEAD
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR
• Patient Weight: 68