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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL EXCLAIM LEAD, 90 CM; SCS PADDLE LEAD
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ABBOTT MEDICAL EXCLAIM LEAD, 90 CM; SCS PADDLE LEAD Back to Search Results
Model Number 3225
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 10/20/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.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 or Problem Description
It was reported that the patient's cervical paddle lead had migrated.As a result, surgical intervention was undertaken wherein the lead was explanted and replaced.Post-operatively, stimulation therapy was restored.
 
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Brand Name
EXCLAIM LEAD, 90 CM
Common Device Name
SCS PADDLE LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key10822803
Report Number1627487-2020-33431
Device Sequence Number3569683
Product Code LGW
UDI-Device Identifier05415067017758
UDI-Public05415067017758
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/11/2020
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? No
Operator of Device Health Professional
Device Expiration Date02/28/2018
Device Model Number3225
Device Catalogue Number3225
Device Lot Number5432855
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 10/20/2020
Initial Report FDA Received Date11/11/2020
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 Age46 YR
Patient Weight68
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