MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number 6660

Device Problems Premature Elective Replacement Indicator (1483); Insufficient Information (3190)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

Event date is estimated.Date of implant is unknown at this time.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the elective replacement indicator (eri) was triggered.As a result, surgical intervention was undertaken on (b)(6) 2019 wherein the ipg was explanted and replaced.

Manufacturer Narrative

Further information was requested but not received.(b)(4).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: INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR
• Type of Device: DBS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 9453714
• MDR Text Key: 170427098
• Report Number: 1627487-2019-13814
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020246
• UDI-Public: 05415067020246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2019
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: 5770941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2017
• 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): Other