MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3660

Device Problem Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2020

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 received the "replace generator soon" message.In turn, surgical intervention may take place to address the issue.

Event Description

It was reported that the patient underwent surgical intervention wherein the scs ipg was explanted and replaced to address the issue.

Manufacturer Narrative

A patient controller communication error message displaying ¿replace generator soon¿ was reported to abbott.The ipg was explanted and replaced due to a true eri.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 incident could not be conclusively determined.

• Brand Name: PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11154728
• MDR Text Key: 226260380
• Report Number: 1627487-2021-00237
• 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
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2020
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: 6263117
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 82