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 Fever (1858); Fluid Discharge (2686)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the ipg site was draining fluid.It was noted the patient had a fever of 102-104 for a couple of days.The physician swabbed and tested the tissue at the ipg site and the test came back clear.The patient was put on iv antibiotics for precaution.

Event Description

Additional information received indicates that the issue was resolved.

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: 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
• 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 9887186
• MDR Text Key: 188349215
• Report Number: 3006705815-2020-01421
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017093
• UDI-Public: 05415067017093
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2021
• Device Model Number: 3772
• Device Catalogue Number: 3772
• Device Lot Number: A000082749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 68