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 11/14/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr.Report#: 1627487-2014-05830.Follow-up revealed one of the patient's ipgs was relocated on (b)(6) 2014.Surgical intervention resolved the patient's 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.

Event Description

The patient has two scs systems (for off-label use).Device 1 of 2.Reference mfr.Report#: 1627487-2014-05830.It was reported one of the patient's ipgs is no longer secure in the pocket due to weight loss.In turn, the patient has been experiencing discomfort.As a result, the patient will undergo surgical intervention to address the issue.Both ipgs are being reported because it is unknown which device is causing discomfort.

Manufacturer Narrative

Correction number: 1627487-07262012-002-r.This ipg serial number is included in field advisories.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: 4304058
• MDR Text Key: 5420899
• Report Number: 1627487-2014-05829
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2012
• Device Model Number: 3788
• Device Lot Number: 3108347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1627487-12192011-003-R
• Patient Sequence Number: 1
• Treatment: MODEL: 1192, SCS ANCHOR; MODEL: 3383, SCS EXTENSION; MODEL: 3189, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 41 YR