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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S-8 LEAD KIT, 60CM LENGTH; SCS LEAD
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ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S-8 LEAD KIT, 60CM LENGTH; SCS LEAD Back to Search Results
Model Number 3286
Medical Device Problem Code Disconnection (1171)
Health Effect - Clinical Code Device Overstimulation of Tissue (1991)
Date of Event 11/13/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Device 1 of 3.Reference mfr report: 1627487-2018-12507, reference mfr report: 1627487-2018-12718.It was reported that the patient experienced overstimulation due to invalid impedances.X-rays were taken and confirmed one of the leads had pulled out of the header.Surgical intervention was taken on (b)(6) 2018 to reconnect the leads and ipg.Issue has been resolved.
 
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Brand Name
LAMITRODE S-8 LEAD KIT, 60CM LENGTH
Common Device Name
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key8135011
Report Number1627487-2018-12506
Device Sequence Number11344192
Product Code GZB
UDI-Device Identifier05415067017833
UDI-Public05415067017833
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/05/2018
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? Yes
Operator of Device Health Professional
Device Expiration Date08/31/2017
Device Model Number3286
Device Lot Number5222320
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 11/13/2018
Initial Report FDA Received Date12/05/2018
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: 3716, SCS IPG; SCS LEAD
Outcome Attributed to Adverse Event Other;
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