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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL EON MINI IPG, 16-CHANNEL RECHARGEABLE; SCS IPG
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ABBOTT MEDICAL EON MINI IPG, 16-CHANNEL RECHARGEABLE; SCS IPG Back to Search Results
Model Number 3788
Medical Device Problem Code Wireless Communication Problem (3283)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 06/21/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported the patient had his scs ipg replaced because the ipg was inoperable.Stimulation therapy was reportedly restored postoperatively.
 
Additional Manufacturer Narrative
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.
 
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Brand Name
EON MINI IPG, 16-CHANNEL RECHARGEABLE
Common Device Name
SCS IPG
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key12125208
Report Number1627487-2021-15377
Device Sequence Number3529722
Product Code LGW
UDI-Device Identifier05414734405300
UDI-Public05414734405300
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 07/29/2021
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 Date05/28/2013
Device Model Number3788
Device Catalogue Number3722
Device Lot Number3382896
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 06/21/2021
Supplement Date Received by Manufacturer07/13/2021
Initial Report FDA Received Date07/06/2021
Supplement Report FDA Received Date07/29/2021
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 Weight77
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