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

Model Number 3788

Device Problems Disconnection (1171); Difficult to Insert (1316); Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/14/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report#: 1627487-2014-25544.It was reported during the patient's (b)(6) ipg replacement procedure (reported under mfr report#: 1627487-2014-25542) the physician experienced difficulty inserting the patient's extension in the replacement ipgs contacts 1-8 header port.In turn, the physician decided to insert the extension in contacts 9-16 header port.Postoperative lead diagnostic testing revealed invalid and high impedances.X-rays identified the extension disconnected from the ipg header.As a result, the physician explanted the ipg after the extension was unable to successfully stay inserted in the ipg header.Additionally, it was reported the physician cut the end of the extension after fracturing it while attempting to insert it into the ipg header.The procedure was extended by 30 minutes.Follow-up revealed a new ipg was implanted and the extension was explanted and replaced on (b)(6) 2014.Effective therapy was restored postoperative.

Manufacturer Narrative

Sjm has limited information related to the patient's medical history an 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 IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: benjyna obasuyi ; 6901 preston rd.; plano, TX 75024 ; 9725264659
• MDR Report Key: 4059574
• MDR Text Key: 21446933
• Report Number: 1627487-2014-25543
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2015
• Device Model Number: 3788
• Device Lot Number: 4332647
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/25/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2014
• Initial Date FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• 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
• Patient Outcome(s): Other