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U.S. Department of Health and Human Services

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

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ABBOTT MEDICAL EON RECHARGEABLE IPG, 16-CHANNEL SCS IPG Back to Search Results
Model Number 3716
Device Problem Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2020
Event Type  Injury  
Manufacturer Narrative
Date of event and therapy date are estimated. The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Related manufacturer reference number: 1627487-2020-48301. It was reported that the pocket site was heating up when the patient attempted to charge. As a result, surgery may occur to address the issue. The patient also had an inoperable ipg, documented in manufacturer reference number: 1627487-2020-48010.
 
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Brand NameEON RECHARGEABLE IPG, 16-CHANNEL
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
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key10932294
MDR Text Key219126169
Report Number1627487-2020-48302
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2009
Device Model Number3716
Device Catalogue Number3716
Device Lot Number66886
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 Received12/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/13/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction Number1627487/07/26/2012/001-C

Patient Treatment Data
Date Received: 12/02/2020 Patient Sequence Number: 1
Treatment
SCS CHARGER
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