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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE 4 LEAD KIT, 60CM LENGTH; SCS PADDLE LEAD
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ABBOTT MEDICAL LAMITRODE 4 LEAD KIT, 60CM LENGTH; SCS PADDLE LEAD Back to Search Results
Model Number 3240
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Erosion (1750)
Date of Event 12/01/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
 
Event or Problem Description
It was reported the patient's lead had eroded through the skin.In turn, the system was explanted in (b)(6) 2020 to address the issue.Exact date of explant unknown.
 
Additional Manufacturer Narrative
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. .
 
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Brand Name
LAMITRODE 4 LEAD KIT, 60CM LENGTH
Common Device Name
SCS PADDLE LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key11769574
Report Number1627487-2021-13761
Device Sequence Number16941923
Product Code LGW
UDI-Device Identifier05414734406192
UDI-Public05414734406192
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
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) 05/12/2021
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? No
Operator of Device Health Professional
Device Expiration Date08/23/2018
Device Model Number3240
Device Catalogue Number3240
Device Lot Number5614578
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 04/16/2021
Supplement Date Received by Manufacturer05/11/2021
Initial Report FDA Received Date05/04/2021
Supplement Report FDA Received Date05/12/2021
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 Age50 YR
Patient Weight91
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