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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 10CM SCS EXTENSION

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ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 10CM SCS EXTENSION Back to Search Results
Model Number 3341
Device Problems Disconnection (1171); High impedance (1291)
Patient Problem Inadequate Pain Relief (2388)
Event Date 03/06/2020
Event Type  Injury  
Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report. Date of event is estimated.

 
Event Description

Related manufacturer reference number: 1627487-2020-03139 , 1627487-2020-03140. It was reported that the patient had multiple high impedances on a lead. In turn, during surgical intervention it was observed one of the leads was disconnected from the extension. The extension was reconnected, the high impedances persisted and the devices were left implanted. Therapy was restored postoperatively. All of the patient's leads are being reported because it is unknown which lead is liable.

 
Manufacturer Narrative

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.

 
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Brand NameEXTENSION, DUAL 4 CHANNEL 10CM
Type of DeviceSCS EXTENSION
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key9871150
MDR Text Key184632563
Report Number1627487-2020-03141
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/28/2014
Device MODEL Number3341
Device Catalogue Number3341
Device LOT Number3722702
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/07/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/11/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/24/2020 Patient Sequence Number: 1
Treatment
SCS LEAD X2
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