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

Model Number 3228

Device Problem High impedance (1291)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Date 03/11/2024

Event Type  Injury  

Manufacturer Narrative

Section b3: event date is estimated.Section d4: device serial and lit number are unavailable.Section h4: device manufacturer date is unknown.

Event Description

It was reported that the patient was getting ineffective left side coverage from their scs lead.An impedance check indicated that the patient had high impedance on 9 out of the 16 contacts.Surgical intervention may take place at a later date to address the issue.

Event Description

Additional information was received indicating that the patient underwent surgical intervention on (b)(6) 2024 wherein the patient's lead was explanted, replaced, and therapy was restored.

• Brand Name: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 19008585
• MDR Text Key: 338978956
• Report Number: 3006705815-2024-02392
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2024
• Device Model Number: 3228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• 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: SCS IPG (X1).; SCS LEAD EXTENSION (X2).
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 79 KG