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 Inadequate Pain Relief (2388)

Event Date 04/20/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient's ipg was unable to connect with external devices.The device was deemed inoperable, confirmed by the "generator has reached its end of service" message.In turn, surgical intervention may take place to address the issue.

Event Description

Additional information revealed that the patient underwent surgical intervention wherein the ipg was explanted and replaced, resolving the issue.

Manufacturer Narrative

Evaluation codes - changed device code to reflect normal eol.The reported inoperable ipg was confirmed.It was determined the device declared elective replacement indication (eri) and end of life (eol).The cause of the reported observation was due to the device having normal battery depletion to the end of life (eol).

• 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: 10074876
• MDR Text Key: 191558812
• Report Number: 1627487-2020-04793
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2019
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: 6049567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 68