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

Model Number 3772

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

The results/ method and conclusion codes along with investigation results will be provided in the final report.Event date is an estimation.

Event Description

It was reported that the patient is experiencing pocket heating while charging the ipg.As a result, surgical intervention was undertaken wherein the patient's ipg was explanted and replaced.Surgical intervention resolved the issue.

Manufacturer Narrative

As received, reported event for pocket heating while charging was not confirmed.The ipg, after being depleted, was able to fully charge and pass auto test.Pocket heating testing while charging was conducted using the returned ipg and le charger for 10 hours using test method 76-0011 and analyses of the test data revealed that the temperature distributions on the ipg surface were within specification as indicated in compliance in the eon mini product requirements specification.No anomaly was observed that would have affected the operation of the ipg or reported event.

• 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: 10622306
• MDR Text Key: 209755265
• Report Number: 3006705815-2020-31746
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2018
• Device Model Number: 3772
• Device Catalogue Number: 3772
• Device Lot Number: A000026431
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other