• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PRODIGY MRI IPG, 16CH, RECHARGEABLE SCS IPG Back to Search Results
Model Number 3772
Device Problem Wireless Communication Problem (3283)
Patient Problem Inadequate Pain Relief (2388)
Event Date 04/09/2021
Event Type  Injury  
Manufacturer Narrative

Date of event is estimated. During processing of this complaint, attempts were made to obtain patient weight, and but it was not received.

 
Event Description

It was reported the patient lost therapy due to not charging the ipg. The patient has not recharged or used the ipg in approximately four months. The issue was resolved through an ipg replacement. Effective therapy restored post-op.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRODIGY MRI IPG, 16CH, RECHARGEABLE
Type of DeviceSCS 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
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer Contact
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key12388805
MDR Text Key268887983
Report Number3006705815-2021-04024
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/02/2020
Device MODEL Number3772
Device Catalogue Number3772
Device LOT NumberA000061223
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/10/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/03/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/30/2021 Patient Sequence Number: 1
-
-