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

Model Number 3608

Device Problems No Device Output (1435); Premature End-of-Life Indicator (1480); Low impedance (2285)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/01/2014

Event Type  Injury  

Event Description

It was reported the patient's ((b)(6)) ipg was inoperable.It was also reported after 5 months from the patient's implant date, the patient's ipg displayed a low battery message.Diagnostic testing revealed low impedance readings.Subsequently, the patient underwent surgical intervention on (b)(6) 2014, where the ipg was removed and replaced.The patient reported effective therapy postoperative.

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: GENESIS
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: jennifer shepard ; 6901 preston rd.; plano, TX 75024 ; 9725264657
• MDR Report Key: 4001438
• MDR Text Key: 4780690
• Report Number: 1627487-2014-23431
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• 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: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2014
• Device Model Number: 3608
• Device Lot Number: 3776091
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2012
• 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