MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM DRG IMPLANTABLE PULSE GENERATOR; DRG IPG

Model Number 3664

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the patient's controller displayed the "replace generator soon" message.The elective replacement indicator (eri) may have triggered earlier than intended.Troubleshooting steps will be taken to update the software.

Manufacturer Narrative

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 event could not be conclusively determined.

Event Description

Message cleared with the app update.

• Brand Name: PROCLAIM DRG IMPLANTABLE PULSE GENERATOR
• Type of Device: DRG IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10662139
• MDR Text Key: 212709254
• Report Number: 1627487-2020-32456
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067020215
• UDI-Public: 05415067020215
• Combination Product (y/n): N
• PMA/PMN Number: P150004
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2019
• Device Model Number: 3664
• Device Catalogue Number: 3664
• Device Lot Number: 6002068
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 59