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

Model Number 3228

Device Problems Fracture (1260); Impedance Problem (2950)

Patient Problems Fall (1848); Device Overstimulation of Tissue (1991)

Event Date 06/03/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.

Event Description

It was reported the patient began to experience overstimulation after falling.An impedance check revealed impedance issues on multiple contacts.Reprogramming was unable to address the overstimulation.X-rays revealed possible lead fracture.As a result, the patient will undergo surgical intervention on a later date.

Event Description

Follow-up revealed the patient's lead was explanted and replaced.

Event Description

Follow-up revealed surgical intervention addressed the patient's issue.

• Brand Name: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS 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: drew johnson ; 9725264667
• MDR Report Key: 7691719
• MDR Text Key: 114104110
• Report Number: 1627487-2018-06553
• Device Sequence Number: 1
• Product Code: GZB
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2019
• Device Model Number: 3228
• Device Lot Number: 5963550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 07/24/2018; 08/20/2018
• Supplement Dates FDA Received: 08/17/2018; 09/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2017
• 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
• Treatment: MODEL: 3662, SCS IPG
• Patient Outcome(s): Other