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

Model Number 3688

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/26/2014

Event Type  Injury  

Event Description

It was reported the patient's (b)(6) stimulation was turning off every few hours.Preoperative diagnostics revealed no anomalies.In turn, the physician decided to perform surgical intervention to address the issue.During the procedure the physician explanted and replaced the ipg after diagnostic testing.Effective stimulation was restored postoperative.

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: EONC
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: benjyna obasuyi ; 6901 preston rd.; plano, TX 75024 ; 9725264659
• MDR Report Key: 4113296
• MDR Text Key: 4939963
• Report Number: 1627487-2014-25619
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/01/2015
• Device Model Number: 3688
• Device Lot Number: 4271917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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: SCS LEAD, MODEL: UNKNOWN
• Patient Outcome(s): Other