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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL PRODIGY MRI IPG, 16CH, RECHARGEABLE SCS IPG

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ABBOTT MEDICAL 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 06/30/2021
Event Type  Injury  
Manufacturer Narrative

Date of the event is estimated.

 
Event Description

Related manufacturer report 1627487-2021-16386. It was reported that patient had a mri scan and post scan the patient experienced their pain returning. Patient stated the device was placed in surgery mode. Patient denies any traumas or falls. Patient has a wound at their lead and battery side. Patient felt a shocking sensation twice and therefore their stimulation was turned off. Patient stated feeling better. Patient received antibiotics. The ipg and lead was explanted. Patient was stable.

 
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Brand NamePRODIGY MRI IPG, 16CH, RECHARGEABLE
Type of DeviceSCS IPG
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer Contact
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key12333801
MDR Text Key266974896
Report Number1627487-2021-16385
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,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/30/2019
Device MODEL Number3772
Device Catalogue Number3772
Device LOT Number6179740
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/27/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/30/2017
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: 08/17/2021 Patient Sequence Number: 1
Treatment
SCS LEAD
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