MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTEGE MRI IPG; SCS IPG

Model Number 3771

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 08/18/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported that the patient was experiencing a burning/shocking sensation at the ipg site when charging and when therapy is on.Imaging was done which showed excess lead wires being coiled up on top of the ipg between the ipg and skin.In turn, surgical intervention may take place to address the issue.

Event Description

Additional information revealed that the patient underwent surgical intervention wherein the ipg was explanted and replaced, resolving the issue.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: PROTEGE MRI IPG
• 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
• MDR Report Key: 12356033
• MDR Text Key: 267748325
• Report Number: 3006705815-2021-04151
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017086
• UDI-Public: 05415067017086
• 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: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2018
• Device Model Number: 3771
• Device Catalogue Number: 3771
• Device Lot Number: A000030002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 59