MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3660

Device Problem Pocket Stimulation (1463)

Patient Problems Undesired Nerve Stimulation (1980); Burning Sensation (2146)

Event Date 11/25/2022

Event Type  Injury  

Manufacturer Narrative

The date of event is estimated.

Event Description

It was reported that the patient was experiencing heating and shocking sensation at ipg site.As a result, surgical intervention may be undertaken to address the issue.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain patient¿s weight.Further information was requested but not received.The event of shocking sensation & heating at ipg site & not connecting was reported to abbott.On (b)(6) 2024, the patient reported that they are already discussing with a physician to either have the system explanted or replaced due to prior issues under per-(b)(4) (shocking and heating at ipg site).The patient met with their physician on (b)(6) 2024.There was a plan to replace the ipg.There was no intervention planned for the leads.The patient was waiting on cardiac clearance and smoking cessation.As of (b)(6) 2024, surgery was still pending scheduling.The rep was informed the record would be closed and reopened as needed.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: PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• 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: 18890584
• MDR Text Key: 337492460
• Report Number: 3006705815-2024-01734
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020192
• UDI-Public: 05415067020192
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2020
• Device Model Number: 3660
• Device Lot Number: A000059631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2018
• 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
• Treatment: SCS ANCHOR.; SCS LEAD.
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Sex: Female