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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, 16CH, RECHARGEABLE SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PRODIGY MRI IPG, 16CH, RECHARGEABLE SCS IPG Back to Search Results
Model Number 3772
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Wound Dehiscence (1154)
Event Date 08/09/2021
Event Type  Injury  
Manufacturer Narrative

Date of event is estimated.

 
Event Description

It was reported the patient had drainage at the ipg site. Further observation confirmed a small wound dehiscence was found. The patient is on antibiotics and routine dressing exchanges. An incisional wound vac has been ordered. Surgical intervention may take place at a later date.

 
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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 Key12373876
MDR Text Key268346602
Report Number3006705815-2021-04221
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 09/28/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3772
Device Catalogue Number3772
Device LOT NumberA000103187
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 Received09/21/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/12/2020
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: 08/26/2021 Patient Sequence Number: 1
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