MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3662

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

Date of the 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 wireless software update was performed clearing the eri message.The device is providing therapy.

Manufacturer Narrative

A "replace generator soon" message was reported to abbott.Analysis of session reports indicated the battery voltage was still good, and this was a false message.The device was not returned for analysis; however, event details indicate the pc app was updated, and the error message cleared.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.

• Brand Name: PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11083067
• MDR Text Key: 224028795
• Report Number: 1627487-2020-49245
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020222
• UDI-Public: 05415067020222
• 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
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2019
• Device Model Number: 3662
• Device Catalogue Number: 3662
• Device Lot Number: 5855351
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1627487/09/12/2017/001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 100