MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3660

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that diagnostics indicated the elective replacement indicator (eri) triggered earlier than intended.The device was explanted and replaced.It was noted the patient was still receiving stimulation at the time of ipg replacement.

Manufacturer Narrative

The reported event for eri message was confirmed.A review of the ipg logs showed that the first elective replacement indication (eri) was declared on (b)(6) 2019 during a session while connected to a cp.This alert occurs during a cp session when the ipg battery voltage is at or below 2.7v +/- 30mv at the time of the session.The ipg had not logged the elective replacement indication (eri) or the end of life (eol) timestamps and the ipg voltage level was above the ipg eri threshold of 2.644v at the time of explant.The root cause of the reported observation was due to the implantable pulse generator (ipg) having normal battery depletion.As the issue was due to normal battery depletion, it does not meet reportability criteria.

• Brand Name: PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9936341
• MDR Text Key: 186851984
• Report Number: 1627487-2020-03754
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020192
• UDI-Public: 05415067020192
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2018
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: 5564559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR