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

Model Number 3771

Device Problem Disconnection (1171)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/29/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.During processing of this complaint, attempts were made to obtain complete event information.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Device 1 of 3.Related manufacturer reference number: 1627487-2020-04779.Related manufacturer reference number: 1627487-2020-04780.It was reported the patient experienced ineffective stimulation.The patient stated the ipg would not respond to the paddle, and the leads had disconnected from the ipg.To address the issue, the patient stated the ipg was explanted in (b)(6) 2017 (exact date is unknown), and the leads remain insitu.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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
• MDR Report Key: 10069938
• MDR Text Key: 191403336
• Report Number: 3006705815-2020-01905
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017086
• UDI-Public: 05415067017086
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2018
• Device Model Number: 3771
• Device Catalogue Number: 3771
• Device Lot Number: 5435986
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS LEADS (X2); SCS LEADS (X2)
• Patient Outcome(s): Other
• Patient Age: 49 YR