MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/4MM, 60 CM; PERCUTANEOUS LEAD

Model Number 3146

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Undesired Nerve Stimulation (1980)

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown.Date of explant is estimated.During processing of this complaint, attempts were made to obtain complete patient information.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference numbers: 1627487-2020-23381, 1627487-2020-23382.It was reported that the patient experienced uncomfortable stimulation.In turn, the patient underwent surgical intervention wherein the entire scs system was explanted (estimated date: (b)(6) 2019).

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete patient information.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: QUATTRODE LEAD, 3/4MM, 60 CM
• Type of Device: PERCUTANEOUS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10344267
• MDR Text Key: 201435379
• Report Number: 1627487-2020-23383
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401586
• UDI-Public: 05414734401586
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2014
• Device Model Number: 3146
• Device Catalogue Number: 3146
• Device Lot Number: 3593603
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD; SCS PADDLE LEAD
• Patient Outcome(s): Other