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 Seroma (2069)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Device 1 of 2.Related manufacturer reference number: 3006705815-2020-00166.It was reported the patient developed a seroma around the patient¿s lead.According to the patient, the seroma burst, and they were still experiencing some discomfort at the lead site when leaning on this site.

Event Description

Device 1 of 2.Related manufacturer reference number: 3006705815-2020-00166.Follow up information identified the physician explanted the patient¿s scs system.The seroma has resolved.

Manufacturer Narrative

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.

Event Description

Device 1 of 2.Related manufacturer reference number: 3006705815-2020-00166.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• MDR Report Key: 9575279
• MDR Text Key: 174506673
• Report Number: 3006705815-2020-00165
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2020

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: 09/16/2021
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000086607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 01/15/2020; 02/29/2020
• Supplement Dates FDA Received: 02/01/2020; 03/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2019
• 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: SCS LEAD
• Patient Outcome(s): Other
• Patient Weight: 91