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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
Device Problem Wireless Communication Problem (3283)
Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)
Event Date 08/01/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.The unique device identifier (udi) is not provided because serial # is not available.During processing of this incident, attempts were made to obtain complete event, patient and device information.
 
Event Description
It was reported patient lost therapy and ipg was deemed to be inoperable.As such surgical intervention is anticipated to address the issue at a later time.
 
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.
 
Event Description
Additional information received indicated patient had surgical intervention wherein the ipg was replaced and reportedly therapy was restored.
 
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Brand Name
EON MINI IPG, 16-CHANNEL RECHARGEABLE
Type of Device
SCS IPG
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key12522831
MDR Text Key273071732
Report Number1627487-2021-17231
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3788
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age51 YR
Patient Weight98
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