MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PRODIGY IPG; SCS IPG

Model Number 3799

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

Patient Problems Edema (1820); Fibrosis (3167)

Event Date 04/30/2015

Event Type  Injury  

Event Description

The patient (b)(6) has two implantable ipgs.It was reported the patient's ipg (right buttock) was unable to communicate with two charging systems.Troubleshooting attempts were unsuccessful.As a result, surgical intervention was undertaken at which time fluid was observed in the pocket in addition to the presence of fibrous tissue.The physician removed the fluid and relocated the ipg pocket which resolved the communication issue.

Manufacturer Narrative

(b)(4).(device product code) is only populated for submission purposes.This device is not approved for sale in the usa, but is similar to a usa marketed/approved device.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

• Brand Name: PRODIGY IPG
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4838753
• MDR Text Key: 5941170
• Report Number: 1627487-2015-21139
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 3799
• Device Lot Number: 4902760
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2014
• 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: MODEL 3186(2), SCS LEAD
• Patient Outcome(s): Other