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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE 44 LEAD KIT, 90CM LENGTH; SCS LEAD
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ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE 44 LEAD KIT, 90CM LENGTH; SCS LEAD Back to Search Results
Model Number 3262
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/01/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
During processing of this complaint, further event and patient information were unable to be obtained.The date of explant is unknown.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
Device 3 of 3.Reference mfr.Report #: 1627487-2020-22678, reference mfr.Report #: 1627487-2020-22679.It was reported the patient's scs system was explanted for an unknown reason.
 
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Brand Name
LAMITRODE 44 LEAD KIT, 90CM LENGTH
Common Device Name
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key10267875
Report Number1627487-2020-22680
Device Sequence Number13690740
Product Code LGW
UDI-Device Identifier05414734402132
UDI-Public05414734402132
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/13/2020
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 Date03/28/2016
Device Model Number3262
Device Catalogue Number3262
Device Lot Number4510283
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 07/01/2020
Initial Report FDA Received Date07/13/2020
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;
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