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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Type of Reportable Event Serious Injury
Event or Problem Description
Device 3 of 4.Reference mfr.Report number: 1627487-2019-02798.Reference mfr.Report number: 1627487-2019-02799.Reference mfr.Report number: 1627487-2019-02801.It was reported that patient experienced loss of therapy after patient was involved in an automobile accident.As a result, patient underwent surgical intervention on (b)(6) 2019 where the system was explanted.
 
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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 Key8396322
Report Number1627487-2019-02800
Device Sequence Number198388
Product Code LGW
UDI-Device Identifier05414734402132
UDI-Public05414734402132
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/06/2019
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 Date08/28/2014
Device Model Number3262
Device Lot Number3788400
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 02/18/2019
Initial Report FDA Received Date03/06/2019
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 3228, SCS LEAD; MODEL 3383, LEAD EXTENSION; MODEL 3788, SCS IPG
Outcome Attributed to Adverse Event Other;
Patient Weight113
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