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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 8-CHANNEL ADAPTER, MDT, 10CM SCS EXTENSION

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ST. JUDE MEDICAL - NEUROMODULATION 8-CHANNEL ADAPTER, MDT, 10CM SCS EXTENSION Back to Search Results
Model Number 2311
Device Problems Disconnection (1171); High impedance (1291)
Patient Problem Inadequate Pain Relief (2388)
Event Date 06/25/2020
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: 1627487-2020-22721, 3006705815-2020-02750. It was reported after an implant procedure the patient experienced ineffective stimulation due to high impedances. The patient underwent surgical intervention on (b)(6) 2020 where it was discovered one of the adapters was not connected and then reconnected to address the issue. Therapy was restored postoperatively.

 
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Brand Name8-CHANNEL ADAPTER, MDT, 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 Key10270026
MDR Text Key198686763
Report Number1627487-2020-22722
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 07/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/14/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2311
Device Catalogue Number2311
Device LOT Number7352308
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 Received07/16/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/22/2020
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: 07/14/2020 Patient Sequence Number: 1
Treatment
SCS EXTENSION; SCS IPG
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