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

Model Number 3788

Device Problems Failure to Charge (1085); Nonstandard Device (1420); No Device Output (1435); Use of Device Problem (1670)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/25/2014

Event Type  Injury  

Event Description

It was reported the patient failed to recharge the scs system for the past 8 months due to her confusion about the charging process.As a result, the ipg is inoperable.Troubleshooting was attempted to no avail.Surgical intervention may be undertaken as the next course of action to address the issue.

Manufacturer Narrative

(b)(4).This ipg serial number was included in field advisories.Correction/removal numbers: 1627487-07262012-002-r; 1627487-05242011-002-r; 1627487-12192011-003-r.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

Follow-up revealed the patient's ipg was explanted and replaced (with a different model).Surgical intervention resolved the patient's issue.

• 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: 4749779
• MDR Text Key: 5772874
• Report Number: 1627487-2015-08257
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2011
• Device Model Number: 3788
• Device Lot Number: 2872732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2009
• 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 1194, SCS ANCHOR; MODEL 3186, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 45 YR