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

Model Number 3771

Device Problem Device Stops Intermittently (1599)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

It was reported that patient¿s scs ipg was randomly turning on and off following a lithotripsy procedure.Multiple troubleshooting attempts were not able to resolve the issue.As such, patient underwent a surgical procedure on (b)(6) 2018, wherein patient¿s scs ipg was explanted and replaced.Issue has been resolved post operatively.

• 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: mahzad habibi ; 6901 preston road; plano, TX 75024 ; 9723098547
• MDR Report Key: 7537193
• MDR Text Key: 109019714
• Report Number: 3006705815-2018-01225
• Device Sequence Number: 1
• Product Code: LGW
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/23/2018

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: 07/19/2018
• Device Model Number: 3771
• Device Catalogue Number: 3771
• Device Lot Number: A000025940
• Other Device ID Number: 05415067017086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2016
• 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:3166(X2) SCS,LEAD; MODEL:3169(X2) SCS,LEAD; MODEL:3346(X2) SCS,EXTENSION
• Patient Outcome(s): Other
• Patient Weight: 64