MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 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 05/13/2015

Event Type  Death  

Event Description

It was reported the patient passed away.The cause of death is unknown at this time.The patient had recently been in a rehab facility after breaking her shoulder.It is unknown if the patient's devices were still implanted at the time of the patient's death.It is unknown if any devices will be returned to the manufacturer for analysis.

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 (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: tanja hoffman ; 6901 preston road; plano, TX 75024 ; 9723098520
• MDR Report Key: 4816058
• MDR Text Key: 5924549
• Report Number: 1627487-2015-26241
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: 3789
• Device Lot Number: 4890077
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2014
• 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
• Treatment: MODEL 3186(2), SCS LEAD; MODEL 1192(2), SCS ANCHOR
• Patient Outcome(s): Death
• Patient Age: 74 YR