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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL PROTEGE IPG, 16-CHANNEL RECHARGEABLE SCS IPG

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ABBOTT MEDICAL PROTEGE IPG, 16-CHANNEL RECHARGEABLE SCS IPG Back to Search Results
Model Number 3789
Device Problem Wireless Communication Problem (3283)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/01/2017
Event Type  Injury  
Manufacturer Narrative

Date of event is estimated.

 
Event Description

It was reported that the ipg would not communicate with external devices and the ipg was deemed inoperable. It was also reported that patient lost therapy about 4 years back and the ipg stopped functioning on its own. As such surgical intervention took place wherein the ipg was explanted and replaced with a new one. Reportedly effective therapy was restored.

 
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Brand NamePROTEGE IPG, 16-CHANNEL 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 Key12388951
MDR Text Key268885102
Report Number1627487-2021-16625
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 09/13/2021
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 Date07/31/2017
Device MODEL Number3789
Device Catalogue Number3789
Device LOT Number15554511
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 Manufactured08/07/2015
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
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