MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PRODIGY MRI IPG, 16CH, RECHARGEABLE; SCS IPG

Model Number 3772

Device Problem Wireless Communication Problem (3283)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient lost therapy due to ipg being inoperable in (b)(6) 2020.The ipg was not communicating with external devices.As such, surgical intervention took place on (b)(6) 2020 wherein the ipg was explanted and replaced with a new ipg addressing the issue.Reportedly, therapy was restored post operatively.

Manufacturer Narrative

The reported event of inoperable ipg was confirmed.As received, the ipg battery was depleted.The battery was recovered and was able to communicate with a lab patient programmer.However, the ipg would not charge with the lab charging system.Troubleshooting revealed that the inability to charge was isolated to components q15 and q16.Q15 and q16 are fets in the primary regulator circuit that switch on and off to modulate the coil current.Since q15 and q16 were degraded, the absorption of rf energy from the charger was limited and vchg could not maintain sufficient voltage to enable charging.The degraded components q15 and q16 were isolated to charging only and had no effect on stimulation output or communication with a patient programmer.

• Brand Name: PRODIGY MRI IPG, 16CH, RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10350115
• MDR Text Key: 201329248
• Report Number: 1627487-2020-23405
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017093
• UDI-Public: 05415067017093
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2021
• Device Model Number: 3772
• Device Catalogue Number: 3772
• Device Lot Number: 6934470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other