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

Model Number 3799

Device Problems Low impedance (2285); Temperature Problem (3022)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported the patient ((b)(6)) experienced burning/heating sensation with stimulation (date of event unknown).In turn the patient stopped using stimulation.Additionally, the patient experienced pain while sitting/ putting pressure at the ipg site.System diagnostics determined low impedances on the system.Surgical intervention was taken where the ip g was explanted and replaced which resolved the issue.

Manufacturer Narrative

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: 5268453
• MDR Text Key: 32736453
• Report Number: 1627487-2015-20666
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 3799
• Device Lot Number: 5020891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/04/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/18/2015; 01/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2015
• 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