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

Model Number 3772

Device Problems Charging Problem (2892); Temperature Problem (3022); Wireless Communication Problem (3283)

Patient Problems Discomfort (2330); Inadequate Pain Relief (2388)

Event Date 01/18/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.During processing of this complaint, attempts were made to obtain complete event information.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported the patient experienced a heating sensation at the ipg site.The patient experienced difficulty charging the ipg over the course of a week, and it therefore became inoperable.To address the issue, the patient may be awaiting surgical intervention.

Event Description

Follow up information identified the patient experienced heating at the ipg site while charging the ipg.

Event Description

It was reported surgical intervention was undertaken wherein the ipg was explanted and replaced.Surgical intervention addressed the issue.

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.

Event Description

No surgery has been scheduled at this time.If surgery occurs, a supplement report will be submitted.

Manufacturer Narrative

The reported event of no communication /ipg inoperable was confirmed.At receipt, the ipg would not communicate with lab utilities due to a depleted battery.The battery was recovered and the ipg communicated, charged, and was tested to manufacturing specifications using the autotester.Ppe was unable to determine what cause the battery to deplete.

• 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: 9789139
• MDR Text Key: 182042980
• Report Number: 1627487-2020-02275
• 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,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2019
• Device Model Number: 3772
• Device Catalogue Number: 3772
• Device Lot Number: 6173499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other