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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event is estimated.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

It was reported that diagnostics indicated the elective replacement indicator (eri) triggered while ipg voltage was measured above 2.73, indicating that the eri warning was false.The device is providing therapy.

Manufacturer Narrative

A false elective replacement indicator message was confirmed.The device was not returned for analysis; however, logs and/or assessment report were received.Analysis of the records show that the battery voltage level of the device is within specifications.Actions have been taken to prevent reoccurrence.

Event Description

The wireless software update was performed clearing the eri message.

• 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: 12322139
• MDR Text Key: 266588652
• Report Number: 1627487-2021-16257
• 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,consum
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2019
• Device Model Number: 3662
• Device Catalogue Number: 3662
• Device Lot Number: 6115439
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1627487/09/12/2017/001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 70