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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 No Apparent Adverse Event (3189)
Patient Problems No Consequences Or Impact To Patient (2199); Inadequate Pain Relief (2388)
Event Date 02/16/2021
Event Type  Injury  
Manufacturer Narrative

The unique device identifier (udi #) is not provided. 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 Description

Related manufacturer reference number:1627487-2021-01517. It was reported that during a procedure for ipg replacement, the pocket was opened and it was found the lead was broken off at the ipg header. As a result, the procedure was abandoned, with the lead left in place and the ipg was explanted.

 
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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
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key11362181
MDR Text Key233024622
Report Number1627487-2021-01515
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/04/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2010
Device MODEL Number3716
Device Catalogue Number3716
Device LOT Number115157
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 Received03/03/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/17/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/22/2021 Patient Sequence Number: 1
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