MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTEGE MRI IPG; SCS IPG

Model Number 3771

Device Problem Wireless Communication Problem (3283)

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

Event Date 05/16/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided when the evaluation is completed.

Event Description

It was reported the patient was unable to connect to the scs system implantable pulse generator.The patient does not have stimulation.When attempting to connect with the patient programmer a communication error appears.Surgical intervention to replace the patient's generator would be necessary.

Event Description

Additional information received identified the patient's scs system generator was successfully replaced.Stimulation therapy was restored postoperatively.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for evaluation.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: PROTEGE MRI IPG
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• MDR Report Key: 12038026
• MDR Text Key: 257391312
• Report Number: 3006705815-2021-03057
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017086
• UDI-Public: 05415067017086
• 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: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 3771
• Device Catalogue Number: 3771
• Device Lot Number: 5274217
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 122