MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3788

Device Problem Unintended Movement (3026)

Patient Problem Discomfort (2330)

Event Date 11/21/2014

Event Type  Injury  

Event Description

It was reported, the patient experienced discomfort at the ipg pocket site due to the ipg being too superficial.The ipg pocket site was relocated on (b)(6) 2014.Due to the new location the extensions were explanted and replaced.The patient also elected to replace the ipg during the procedure.

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.

• Brand Name: EON MINI IPG, 16-CHANNEL RECHARGEABLE
• 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: 4338259
• MDR Text Key: 5143609
• Report Number: 1627487-2014-12862
• 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: 11/21/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2015
• Device Model Number: 3788
• Device Lot Number: 4274699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2014
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2013
• 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: MODEL 3166(4), SCS LEADS; MODEL 3343(2), SCS EXTENSIONS
• Patient Outcome(s): Other
• Patient Age: 35 YR