MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, 30CM; SCS EXTENSION

Model Number 3383

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

Patient Problem Hematoma (1884)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

Date of the event is estimated.The investigation results will be provided in the final report.

Event Description

Device 3 of 3.Related manufacturer reference number: 1627487-2020-21431, related manufacturer reference number: 1627487-2020-21432.It was reported the patient experienced swelling a heavy bruising at the ipg site following an ipg revision at the patient¿s abdomen (please see reference mfr report#:1627487-2020-21429).Further investigation found the patient had developed a large hematoma that was the size of an orange at the ipg site.To address the issue, the physician explanted the ipg and opted to cut the extensions on (b)(6) 2020.The leads were left insitu.Cultures were negative for infection.Additional information included that the patient is considered to be underweight, but did not lose any weight from the time of implant.

Event Description

Follow up information identified the patient¿s hematoma has resolved, and the patient is doing well.

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.

• Brand Name: EXTENSION, 30CM
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10125815
• MDR Text Key: 194297651
• Report Number: 1627487-2020-21433
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402323
• UDI-Public: 05414734402323
• Combination Product (y/n): N
• PMA/PMN Number: K960728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2021
• Device Model Number: 3383
• Device Catalogue Number: 3383
• Device Lot Number: 7252609
• 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: SCS EXTENSION; SCS IPG
• Patient Outcome(s): Other