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

Model Number 3788

Device Problems Disconnection (1171); Pocket Stimulation (1463)

Patient Problems Fall (1848); Inadequate Pain Relief (2388)

Event Date 06/18/2015

Event Type  Injury  

Event Description

Device 1 of 3.Reference mfr.Report#: 1627487-2015-23377.Reference mfr.Report#: 1627487-2015-23378.It was reported, the patient experienced a severe fall and impacted the ipg site.X-rays were taken which showed one lead had pulled out of the ipg header while the other remained correctly placed.It was also reported, the sjm representative was able to provide stimulation to the patient 's legs by using the lead that remained connected to the ipg, however, the patient complained of having stimulation at the ipg pocket site.Follow-up information revealed the patient underwent surgical intervention on (b)(6) 2015, where the ipg was explanted and replaced with a new model.Further follow-up revealed the patient was programmed post-operative and has effective therapy.The patient is no longer experiencing an issue and is doing well.The reported issue is now resolved.Please note: it is unknown which one of the patient's two leads pulled out of the header.Therefore, both are being reported.

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.

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.

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

Device 1 of 3.Reference mfr.Report#: 1627487-2015-23377.Reference mfr.Report#: 1627487-2015-23378.

• 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: 4906784
• MDR Text Key: 22162215
• Report Number: 1627487-2015-23376
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: 3788
• Device Lot Number: 4452851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 51 YR