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

Model Number 3788

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 03/27/2014

Event Type  Injury  

Event Description

Device 3 of 3.Reference mfr report numbers: 1627487-2014-05269, 05270.

Manufacturer Narrative

Sjm has limited info 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: EON MINI
• 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
• Manufacturer Contact: ahmad johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 3783089
• MDR Text Key: 17987924
• Report Number: 1627487-2014-05271
• Device Sequence Number: 1
• Product Code: GZB
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2014

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: 04/01/2015
• Device Model Number: 3788
• Device Catalogue Number: 14102152
• Device Lot Number: 4022207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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: IMPLANT DATE:; SCS EXTENSION: MODEL 3341; IMPLANT DATE:; SCS ANCHORS: MODEL 1192 (X3)
• Patient Outcome(s): Other
• Patient Age: 48 YR