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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE 44C LEAD KIT, 60CM LENGTH; SCS LEAD
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ABBOTT MEDICAL LAMITRODE 44C LEAD KIT, 60CM LENGTH; SCS LEAD Back to Search Results
Model Number 3245
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/15/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Date of explant is unknown.During processing of this complaint, attempts were made to obtain patient¿s weight.Further information was requested but not received.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 or Problem Description
Related manufacturer reference number: 1627487-2020-33023.Related manufacturer reference number: 1627487-2020-33025.It was reported that patient underwent surgical intervention for unknown reason at unknown date, wherein the leads and ipg were explanted.No additional information was provided.
 
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Brand Name
LAMITRODE 44C LEAD KIT, 60CM LENGTH
Common Device Name
SCS LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key10759742
Report Number1627487-2020-33026
Device Sequence Number3385674
Product Code LGW
UDI-Device Identifier05414734402088
UDI-Public05414734402088
Combination Product (Y/N)N
Initial Reporter StateAR
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/29/2020
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 Date11/28/2015
Device Model Number3245
Device Catalogue Number3245
Device Lot Number4363399
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 10/15/2020
Initial Report FDA Received Date10/29/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
MODEL 3183, SCS LEAD; MODEL 3788, SCS IPG
Outcome Attributed to Adverse Event Other;
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