MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION GENESIS

Model Number 3608

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Shock (2072); Discomfort (2330); Inadequate Pain Relief (2388)

Event Date 12/17/2013

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report: 1627487-2014-10008.It was reported the pt (united kingdom) is experiencing severe shocking sensations from his scs system.As a result, the pt has decreased his use of scs therapy.The pt reported stimulation will stop on its own, then return strongly before returning back to normal.The pt also stated that he has to turn stimulation up higher to be able to feel it.Reprogramming did not resolve the issue.It was noted that the implanting physician has retried; therefore, the pt is searching for a new physician to determine the next course of action.

Manufacturer Narrative

Sjm has limited information related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: GENESIS
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: karin bechler ; 6901 preston rd.; plano, TX 75024 ; 9723092511
• MDR Report Key: 3682878
• MDR Text Key: 18853685
• Report Number: 1627487-2014-10007
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2011
• Device Model Number: 3608
• Device Lot Number: 2746416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2009
• 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