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

Model Number 3228

Device Problems Disconnection (1171); High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturing report number: 1627487-2020-00987.It was reported that the patient's stimulation was decreasing by itself.Troubleshooting confirmed the system was autoreducing.Follow up identified that one of the leads disconnected causing high impedances on a lead.Surgical intervention may be pending for this issue.

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

Follow up identified that the patient underwent surgical intervention wherein the leads were explanted and replaced, restoring therapy.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 9644209
• MDR Text Key: 176944814
• Report Number: 1627487-2020-00986
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017253
• UDI-Public: 05415067017253
• 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
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2020
• Device Model Number: 3228
• Device Catalogue Number: 3228
• Device Lot Number: 6277666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 91