MAUDE Adverse Event Report: ABBOTT MEDICAL PROTEGE IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3789

Device Problem Wireless Communication Problem (3283)

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

Event Date 03/08/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.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 incident could not be conclusively determined.

Event Description

It was reported patient lost stimulation as unable to charge the ipg.It was deemed that the ipg was inoperable as the company manufacturers were unable to communicate with external devices.As a result, surgical intervention took place wherein the ipg was replaced and reportedly effective therapy was restored.

Manufacturer Narrative

Correction section d6b-the explant date should have been (b)(6) 2021 rather than 09/08/21.

Event Description

Additional report received indicated patient had the replacement surgery on (b)(6) 2021.

• Brand Name: PROTEGE IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12522767
• MDR Text Key: 273083718
• Report Number: 1627487-2021-17201
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734405690
• UDI-Public: 05414734405690
• 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
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Model Number: 3789
• Device Catalogue Number: 3789
• Device Lot Number: 4549495
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 95