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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 Battery Problem (2885)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 03/22/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event or Problem Description
It was reported the patient's ipg failed to establish communication with external devices.A manufacturer representative confirmed the issue and the ipg was deemed inoperable.In turn, the patient underwent surgical intervention wherein the ipg was explanted and replaced to address 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 Key11607531
Report Number1627487-2021-12810
Device Sequence Number3667791
Product Code LGW
UDI-Device Identifier05415067017369
UDI-Public05415067017369
Combination Product (Y/N)N
Initial Reporter StateTX
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) 04/02/2021
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? Yes
Operator of Device Health Professional
Device Expiration Date01/31/2017
Device Model Number3688
Device Catalogue Number3688
Device Lot Number4977487
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 03/22/2021
Initial Report FDA Received Date04/02/2021
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 Weight79
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