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

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 09/04/2013

Event Type  Injury  

Event Description

The pt (b)(6) was a participant in a clinical study.It was reported the pt experienced pain at the ipg site.The pt was hospitalized from (b)(6) 2013, during which time, the ipg was explanted and replaced with a smaller ipg.The new ipg was implanted in a new site which resolved the reported issue.It was noted the pt was still receiving stimulation prior to the procedure.Please note: additional device info has been requested; however, no further info was available at the time of this report.

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: UNK
• 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: 3810586
• MDR Text Key: 4383756
• Report Number: 1627487-2014-10104
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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