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

Model Number 3772

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 06/18/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported that patient 's wound at ipg site is not healing post implant.Surgical intervention may take place to address the issue.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.During processing of this incident, attempts were made to obtain complete patient information.

• Brand Name: PRODIGY MRI IPG, 16CH, RECHARGEABLE
• 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: 12125904
• MDR Text Key: 260238898
• Report Number: 3006705815-2021-03283
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2022
• Device Model Number: 3772
• Device Catalogue Number: 3772
• Device Lot Number: A000104275
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 07/26/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR