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

Model Number 3228

Device Problems Therapy Delivered to Incorrect Body Area (1508); Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that lead migration issue was observed resulting in the patient experiencing ineffective stimulation.Lead revision was performed on (b)(6) 2020.Wherein the lead was relocated from t12 position to l1 position.There were no complications during the procedure.Patient was stable.

Event Description

The issue was due to the lead being relocated to obtain better coverage and not due to lead migration.

• 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: 10353389
• MDR Text Key: 201334649
• Report Number: 1627487-2020-23478
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017253
• UDI-Public: 05415067017253
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: 3228
• Device Catalogue Number: 3228
• Device Lot Number: 6801971
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 59