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

Model Number 3788

Device Problems Migration or Expulsion of Device (1395); Device Inoperable (1663); Improper or Incorrect Procedure or Method (2017)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/03/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report number; 1627487-2014-25315.It was reported the patient's ipg was inoperable due to not recharging the device as recommended.Additionally, the pt was not receiving adequate pain relief due to lead migration.In turn, the patient's ipg and lead were explanted and replaced.Effective stimulation was restored post-op.

Manufacturer Narrative

Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: EON MINI
• 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
• Manufacturer Contact: benjyna obasuyi ; 6901 preston rd.; plano, TX 75024 ; 9725264659
• MDR Report Key: 3798941
• MDR Text Key: 19924210
• Report Number: 1627487-2014-25314
• 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: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

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: 10/01/2013
• Device Model Number: 3788
• Device Lot Number: 3527439
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 04/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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: 58 YR