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

Model Number 3660

Device Problems Premature Elective Replacement Indicator (1483); Insufficient Information (3190)

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

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported patients pc displayed the replace generator soon message.No further action taken at this time.

Manufacturer Narrative

The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.

Event Description

Additional information received indicated that diagnostics indicated the elective replacement indicator (eri) triggered earlier than intended.The device has the appropriate level of battery voltage to provide therapy.Patients app was unable to be updated.

Manufacturer Narrative

A system displaying the ¿replace generator soon¿ warning message was reported to abbott.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.The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.

• 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: 11119084
• MDR Text Key: 225154202
• Report Number: 1627487-2021-00104
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2020
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000061447
• 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
• Removal/Correction Number: 1627487/09/12/2017/001-C
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 77