MAUDE Adverse Event Report: ST. JUDE MEDICAL -NEUROMODULATION EON MINI; SCS LEAD

Model Number 3788

Device Problems Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Fall (1848)

Event Date 06/02/2014

Event Type  Injury  

Event Description

It was reported the patient suffered a fall approximately (b)(6), 2014 (exact date unknown) and since then the patient is recharging her ipg daily for 2 hours.Prior to the fall she did not need to recharge as frequently or as long.The sjm representative met with the patient and was unable to maintain communication with the charging system regardless of the placement of the antenna of the charger.A replacement charger was unable to resolve the issue.Follow up information identified the depth of the ipg was a potential cause of the issue.The patient underwent a surgical procedure to remove and replace the ipg.Intra-operatively, communication was confirmed with the ipg and the charging system and programmer.Xray imagery confirmed connections in the header.

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
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL -NEUROMODULATION; plano TX
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 3960904
• MDR Text Key: 17615419
• Report Number: 1627487-2014-26584
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2015
• Device Model Number: 3788
• Device Lot Number: 4192461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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: IMPLANT DATE:; SCS LEAD, MODEL: 3186 (2); SCS ANCHOR, MODEL 1192 (2); IMPLANT DATE:
• Patient Age: 48 YR