MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTÉGÉ MRI IPG; SCS IPG

Model Number 3771

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

Patient Problem Abscess (1690)

Event Date 01/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).If the product is returned, it will not be analyzed as the complaint of infection can not be confirmed via laboratory testing.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.

Event Description

Device 1 of 2.Reference mfr report #1627487-2016-00665.It was reported the patient was admitted to the hospital due to symptoms of sepsis and an abscess developed near one of the ipg sites.

Event Description

Device 1 of 4.Reference mfr report numbers: 1627487-2016-00665, 1627487-2016-00795, 1627487-2016-00797.Device 3 and 4 were added to address the leads.Note: as it is unknown which devices were explanted, all are being reported.It was reported one of the patient's system was explanted.The patient is currently being treated with iv antibiotics.

Event Description

Device 1 of 4.Reference report numbers: 1627487-2016-00665; 1627487-2016-00795; 1627487-2016-00797.It was determined only one ipg was explanted on (b)(6) 2016 (device 1).Both of the leads were explanted (devices 3 & 4).Device 2 remains implanted.

• Brand Name: PROTÉGÉ MRI IPG
• 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: connie timmons ; 9723098054
• MDR Report Key: 5441401
• MDR Text Key: 38338087
• Report Number: 3006705815-2016-00057
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2016

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: 06/30/2017
• Device Model Number: 3771
• Device Lot Number: 5144567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2016
• Initial Date FDA Received: 02/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/19/2016; 03/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2015
• 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: 43 YR