• 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 Problems Disconnection (1171); Improper or Incorrect Procedure or Method (2017)
Patient Problem Inadequate Pain Relief (2388)
Event Date 06/24/2018
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. The directions for use states that the implant must be charged every 30 days to avoid battery depletion. Based on the information received, the cause of the reported incident is related to user error.

 
Event Description

Related manufacturer report number: 3006705815-2020-02710, 3006705815-2020-02711. It was reported that the patient's leads had pulled out 2 years ago and could not use the device without feeling a shocking sensation. It was noted the patient had a fall around that time of the lead pull out. In turn, the patient has not used or charged their system since then, leading to the ipg becoming inoperable. As a result, the patient may undergo surgical intervention to address the issue.

 
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
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key10276304
MDR Text Key198889686
Report Number3006705815-2020-02712
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
Report Date 07/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/01/2018
Device MODEL Number3772
Device Catalogue Number3772
Device LOT NumberA000031620
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 Received06/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2016
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: 07/15/2020 Patient Sequence Number: 1
Treatment
SCS LEAD (2)
-
-