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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PRODIGY MRI IPG SCS IPG Back to Search Results
Model Number 3772
Device Problem Device Stops Intermittently (1599)
Patient Problem Inadequate Pain Relief (2388)
Event Date 06/16/2017
Event Type  Injury  
Manufacturer Narrative

The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. The manufacturer defers to the patient's physician regarding medical history.

 
Event Description

It was reported the patient complained when she charged the scs ipg, her scs system would shut off. Subsequently, the patient's scs ipg was replaced with a new one.

 
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Brand NamePRODIGY MRI IPG
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
arnlfo ochoa
6901 preston road
plano, TX 75024
9723098090
MDR Report Key7394472
MDR Text Key104247432
Report Number3006705815-2018-00726
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 CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/12/2018
Device MODEL Number3772
Device LOT NumberA000030281
OTHER Device ID Number05415067017093
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/26/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/01/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/12/2016
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: 04/03/2018 Patient Sequence Number: 1
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