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

Model Number 3788

Device Problems Fluid/Blood Leak (1250); Nonstandard Device (1420); Pocket Stimulation (1463); Detachment of Device or Device Component (2907)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

Recall: 1627487-12192011-003-r.This ipg serial number was included in field advisories.(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.(b)(4).

Event Description

It was reported, the patient is experiencing electrical sensations at the ipg site when stimulation is turned on.The patient stated, the sensations occur in her collarbone area where the leads enter into the ipg.It is unknown if the sensations occur with the stimulation turned off.It was noted, the sensations are intermittent.Follow-up information revealed the patient underwent surgical intervention on (b)(6) 2015, where the patient's ipg was explanted and replaced with a different model.It was also reported during the procedure, the physician removed the set screw from the 1-8 port of the ipg, at that time, the set screw and housing pulled out of the header.Diagnostics did not reveal any anomalies.The physician noted possible fluid intrusion at the ipg header due to the set screw housing being loose.

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: 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: 5174704
• MDR Text Key: 29175502
• Report Number: 1627487-2015-23623
• 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: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2012
• Device Model Number: 3788
• Device Lot Number: 3158302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-002-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other