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

Model Number 3772

Device Problem Pocket Stimulation (1463)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).Date of event is estimated.

Event Description

It was reported the patient experienced shocking at the ipg site.Surgical intervention took place wherein the ipg was explanted and replaced to resolve the issue.

Manufacturer Narrative

The reported event of shocking at the ipg site was not confirmed.The return ipg passed all functional testing (bench and autotest).No root cause was identified for the reported event.

• Brand Name: PRODIGY MRI
• 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: 12190039
• MDR Text Key: 262257067
• Report Number: 3006705815-2021-03397
• 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: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2019
• Device Model Number: 3772
• Device Catalogue Number: 3772
• Device Lot Number: 6533140
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1