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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, 30CM SCS EXTENSION

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ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, 30CM SCS EXTENSION Back to Search Results
Model Number 3383
Device Problem Disconnection (1171)
Patient Problem Inadequate Pain Relief (2388)
Event Date 09/10/2020
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Related manufacturer reference numbers: 1627487-2020-31960, 1627487-2020-31961, 1627487-2020-31962. It was reported that the patient experienced ineffective stimulation since implant. Reprogramming was attempted, but did not restore effective stimulation. In turn, surgical intervention was undertaken on (b)(6) 2016, wherein the entire scs system was explanted. Post-operatively, it was discovered the paddle lead had pulled out. It is unknown if the lead pulled out from the extensions or the ipg, therefore all devices are being reported.

 
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Brand NameEXTENSION, 30CM
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 Key10599915
MDR Text Key208957934
Report Number1627487-2020-31963
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 CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/28/2015
Device MODEL Number3383
Device Catalogue Number3383
Device LOT Number4110721
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 Received12/17/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/10/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 09/29/2020 Patient Sequence Number: 1
Treatment
SCS EXTENSION; SCS IPG; SCS PADDLE LEAD
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