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

Model Number 3772

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 01/22/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.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¿s ipg gets hot while recharging.In turn, surgical intervention may take place at a later date to address the issue.

Event Description

Additional information received indicates that only the ipg was explanted.The lead remains implanted.

Manufacturer Narrative

The reported event of ipg gets hot during recharge was not confirmed.The device was placed in a heated chamber and after several hours of recharge, the rise in temperature was within the product requirement specifications for heat generation during use.Also, the return ipg passed all functional testing at lab bench and onto the autotester.

Event Description

Additional information received indicates that that surgical intervention took place on (b)(6) 2020 wherein the ipg was explanted and replaced with a new ipg to address the issue.

Manufacturer Narrative

Date of event is estimated.

Event Description

Additional information received indicates that the physician decided to explant the entire system on (b)(6) 2020.The issue regarding ipg gets hot while recharging has been resolved.Therapy has been confirmed post operatively.

• 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: 9765262
• MDR Text Key: 181219993
• Report Number: 1627487-2020-02018
• 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,Followup,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2018
• Device Model Number: 3772
• Device Catalogue Number: 3772
• Device Lot Number: 5416720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 3186
• Patient Outcome(s): Other
• Patient Age: 55 YR