MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM; SCS PADDLE LEAD

Model Number 3228

Device Problem Disconnection (1171)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturer reference numbers: 1627487-2020-31960, 1627487-2020-31962, 1627487-2020-31963.It was reported that the patient experienced ineffective stimulation since implant.Reprogramming was attempted, but did not restore effective stimulation.In turn, surgical intervention was undertaken on (b)(6) 2016, wherein the entire scs system was explanted.Post-operatively, it was discovered the paddle lead had pulled out.It is unknown if the lead pulled out from the extensions or the ipg, therefore all devices are being reported.

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: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS PADDLE LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10599899
• MDR Text Key: 208957564
• Report Number: 1627487-2020-31961
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401913
• UDI-Public: 05414734401913
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2015
• Device Model Number: 3228
• Device Catalogue Number: 3228
• Device Lot Number: 4369824
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS EXTENSION (X2); SCS IPG; SCS EXTENSION (X2); SCS IPG
• Patient Outcome(s): Other