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

Model Number 3688

Device Problem Battery Problem (2885)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/16/2013

Event Type  Injury  

Event Description

The pt ((b)(6)) took part in a clinical study.It was reported the pt was hospitalized from (b)(6) 2013, during which time the ipg was explanted and replaced due to battery depletion.Therapy was restored following the procedure.

Manufacturer Narrative

Sjm has limited information 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: EONC
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: karin bechler ; 6901 preston rd.; plano, TX 75024 ; 9723092511
• MDR Report Key: 3710639
• MDR Text Key: 4338277
• Report Number: 1627487-2014-10082
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/05/2014

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: 01/01/2013
• Device Model Number: 3688
• Device Lot Number: 3581350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2014
• Initial Date FDA Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• 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): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 110