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

Model Number 3662

Device Problem Wireless Communication Problem (3283)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/28/2021

Event Type  Injury  

Manufacturer Narrative

The reported observation of ¿ipg not working¿ was confirmed. The analysis results concluded the inability to establish communication between the programmer and the implantable pulse generator (ipg) was due to the device entering the service application state. Per the patient, they did not undergo any medical procedures at the time the device entered the service application state. The root cause of the device entering the service application state was not ascertained. The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.

Event Description

It was reported the patients ipg was no longer communicating with external devices. It was believed the device had reached normal end of life based on the age of the device. As a result, surgical intervention was undertaken (b)(6) 2021 wherein the ipg was explanted and replaced. The ipg was returned to be investigated. Investigation concluded the inability to establish communication between the programmer and the implantable pulse generator (ipg) was due to the device entering the service application state. This was determined to be a device malfunction and not normal end of life for the device.

• Brand Name: PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 13965185
• MDR Text Key: 288283387
• Report Number: 1627487-2022-01727
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/04/2018
• Device Model Number: 3662
• Device Catalogue Number: 3662
• Device Lot Number: 5649571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487/06/02/2017/001-C

Patient Treatment Data

Date Received: 03/31/2022 Patient Sequence Number: 1