MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROTEGE IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3789

Device Problems Failure to Charge (1085); Wireless Communication Problem (3283)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided on the final report.Further information was requested but not received.

Event Description

It was reported that the implantable pulse generator was unable to establish communication with external devices.Patient was having charging issues with her charger.A surgical intervention is anticipated in the near future.No further information is available at this time.

Event Description

New information received states that the implantable pulse generator (ipg) was explanted and a new device was implanted.There were no complications during the procedure and therapy was restored post procedure.Patient was stable.

Manufacturer Narrative

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.

• Brand Name: PROTEGE IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10197888
• MDR Text Key: 196577034
• Report Number: 1627487-2020-22180
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 3789
• Device Catalogue Number: 3789
• Device Lot Number: 4879896
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 77