MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PRODIGY MRI IPG, 16CH, RECHARGEABLE; SCS IPG

Model Number 3772

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Fever (1858); Post Operative Wound Infection (2446)

Event Date 09/19/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported that patient experienced infection at the ipg site.Reportedly, fluid was leaking out of the incision site.Patient was treated with antibiotics.

Event Description

Additional information received identified that the infection was resolved.

Manufacturer Narrative

The device history record was reviewed to ensure proper packaging and sterility.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: PRODIGY MRI IPG, 16CH, RECHARGEABLE
• 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: 12591138
• MDR Text Key: 275210265
• Report Number: 3006705815-2021-04885
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017093
• UDI-Public: 05415067017093
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2023
• Device Model Number: 3772
• Device Catalogue Number: 3772
• Device Lot Number: A000111837
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 91