MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROTEGE IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3789

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/21/2014

Event Type  Death  

Event Description

Device 2 of 2.Reference mfr report#1627487-2014-01824.

Manufacturer Narrative

(b)(4).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: PROTEGE IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024

plymouth 

• MDR Report Key: 4348238
• MDR Text Key: 5174723
• Report Number: 1627487-2014-01825
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Model Number: 3789
• Device Lot Number: 4549495
• Other Device ID Number: 05414734405690
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MODEL 3186(2), SCS LEAD, IMPLANT DATE; MODEL 3149(4), SCS LEAD, IMPLANT DATE:; MODEL 1192(2), SCS ANCHOR, IMPLANT DATE:; MODEL 3341(2), SCS EXTENSION, IMPLANT DATE:
• Patient Outcome(s): Death
• Patient Age: 57 YR