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

Model Number 6660

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

The results, method, and conclusion codes along with the investigation results will be provided in final report.

Event Description

Related manufacturer reference number: 1627487-2019-11074, related manufacturer reference number: 1627487-2019-11076.It was reported during an ipg replacement procedure for normal end of life the physician was unable to remove the extensions from the ipg and damaged the ipg header.The physician attempted to insert the extensions into a new ipg.The extensions could not be fully inserted so the extensions were explanted and replaced resolving the issue.

Manufacturer Narrative

The reported event the ipg was depleted was confirmed.As received, the ipg displayed the ¿replace generator ¿.The uep inductive tool showed an eri time stamp had been logged.The device was running the therapy application.Once the eri was set to zero, ble communication could be established.A longevity calculation confirmed normal battery depletion based on average device usage using the patient parameters provided.The reported extension insertion and removal issue was not confirmed.The ipg was returned with extensive damage to port 9-16 of the header.The electrodes were unseated and multiple feed through wires were broken.The damage observed is consistent with the device being subjected to an overstress condition during the explant procedure.This is consistent with the event details that reported the ¿header got broken with forceps¿.As the condition of the ipg prior to explant could not be ascertained, the allegation the extensions could not be inserted or removed from the header could not be conclusively determined.

Event Description

Related manufacturer reference number: 1627487-2019-11074.Related manufacturer reference number: 1627487-2019-11076.

• Brand Name: INFINITY¿ 5 IPG
• 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: 9139931
• MDR Text Key: 161207749
• Report Number: 1627487-2019-11077
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020246
• UDI-Public: 05415067020246
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2019
• Device Model Number: 6660
• Device Lot Number: 6014575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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