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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE TRIPOLE 16 LEAD, 60 CM; SCS PADDLE LEAD
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ABBOTT MEDICAL LAMITRODE TRIPOLE 16 LEAD, 60 CM; SCS PADDLE LEAD Back to Search Results
Model Number 3219
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 10/07/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.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
It was reported that patient experienced a fall which resulted to lead migration.As a result the surgical intervention was undertaken where in the lead was explanted and replaced addressing the issue.
 
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Brand Name
LAMITRODE TRIPOLE 16 LEAD, 60 CM
Common Device Name
SCS PADDLE LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key10827135
Report Number1627487-2020-33447
Device Sequence Number1114138
Product Code LGW
UDI-Device Identifier05415067017628
UDI-Public05415067017628
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2019
Reporter Type Manufacturer
Report Source consumer
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 Date06/30/2017
Device Model Number3219
Device Catalogue Number3219
Device Lot Number5149289
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 10/23/2020
Initial Report FDA Received Date11/12/2020
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 Weight68
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