MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number 6662

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

¿the device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.¿.

Event Description

It was reported that diagnostics indicated the elective replacement indicator (eri) triggered earlier than intended.The wireless software update was performed clearing the eri message.The device is providing therapy.

Manufacturer Narrative

The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.

• Brand Name: INFINITY¿ 7 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: 9510467
• MDR Text Key: 177184285
• Report Number: 1627487-2019-14177
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020260
• UDI-Public: 05415067020260
• Combination Product (y/n): N
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2019
• Device Model Number: 6662
• Device Lot Number: 6070163
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/26/2019
• Supplement Dates FDA Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487/09/12/2017/001-C
• Patient Sequence Number: 1
• Patient Weight: 64