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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE TRIPOLE 16C LEAD, 60 CM; SCS PADDLE LEAD
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ABBOTT MEDICAL LAMITRODE TRIPOLE 16C LEAD, 60 CM; SCS PADDLE LEAD Back to Search Results
Model Number 3214
Medical Device Problem Code Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 03/04/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.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: 3006705815-2021-01325.It was reported that patient experienced ineffective therapy.As a result, surgical intervention was undertaken wherein lead and ipg were explanted and replaced.Effective therapy was restored post operatively.
 
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Brand Name
LAMITRODE TRIPOLE 16C LEAD, 60 CM
Common Device Name
SCS PADDLE LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key11557692
Report Number1627487-2021-02295
Device Sequence Number3828597
Product Code LGW
UDI-Device Identifier05414734406154
UDI-Public05414734406154
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/23/2021
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 Date08/16/2020
Device Model Number3214
Device Catalogue Number3214
Device Lot Number6585709
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 03/04/2021
Initial Report FDA Received Date03/23/2021
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;
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