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

Model Number 3789

Device Problem Wireless Communication Problem (3283)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/11/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.During processing of this complaint, attempts were made to obtain complete event, patient and device information.Further information was requested but not received.

Event Description

It was reported that the ipg failed to establish communication with external devices.The ipg was deemed inoperable and patient lost therapy.As a result, surgical intervention was undertaken wherein the ipg was explanted and replaced.Effective therapy was restored post operatively.

Manufacturer Narrative

A patient experiencing an inoperable ipg was reported to abbott.The patient ipg was explanted and replaced.Therapy was restored.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 is consistent with the battery reaching end of life.

• Brand Name: PROTEGE IPG, 16-CHANNEL RECHARGEABLE
• 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: 15215034
• MDR Text Key: 297760597
• Report Number: 1627487-2022-04012
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734405690
• UDI-Public: 05414734405690
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: 3789
• Device Catalogue Number: 3789
• Device Lot Number: 4894414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCS ANCHOR (X2); SCS LEAD (X3)
• Patient Outcome(s): Other
• Patient Sex: Male