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

Model Number 3660

Device Problem Wireless Communication Problem (3283)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Date 08/06/2021

Event Type  Injury  

Manufacturer Narrative

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.Date of event is estimated.

Event Description

It was reported the patients ipg became inoperable following an unrelated procedure wherein the device was not placed into 'surgery mode'.As a result, surgical intervention was undertaken wherein the ipg was explanted and replaced.

Manufacturer Narrative

An inoperable implant was reported to abbott.The system was not set to surgery mode while the patient underwent an unrelated surgery where electro-cautery may have been used.The implant was not returned for analysis.A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.Based on the information received, the cause of the reported incident is consistent with user error.

• 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: 12350324
• MDR Text Key: 267551028
• Report Number: 1627487-2021-16483
• 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
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2019
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: 6198499
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 77