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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL EON C 16-CHANNEL IPG; SCS IPG
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ABBOTT MEDICAL EON C 16-CHANNEL IPG; SCS IPG Back to Search Results
Model Number 3688
Medical Device Problem Code Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code Shock (2072)
Date of Event 07/08/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
 
Event or Problem Description
It was reported that patient experienced shocking sensation at the ipg site.As a result, the ipg was explanted addressing the issue.
 
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Brand Name
EON C 16-CHANNEL IPG
Common Device Name
SCS IPG
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key12253246
Report Number1627487-2021-15941
Device Sequence Number5002472
Product Code LGW
UDI-Device Identifier05415067017369
UDI-Public05415067017369
Combination Product (Y/N)N
Initial Reporter StateNE
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date10/31/2017
Device Model Number3688
Device Catalogue Number3688
Device Lot Number5286178
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/13/2021
Initial Report FDA Received Date07/30/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Weight66
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