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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/6MM, 30 CM SCS LEAD

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ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/6MM, 30 CM SCS LEAD Back to Search Results
Model Number 3153
Device Problems Disconnection (1171); High impedance (1291)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/24/2020
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

Device 1 of 3; related manufacturer reference number: 1627487-2020-23247, related manufacturer reference number: 1627487-2020-23248. It was reported the patient showed high impedances on two contacts, although stimulation was effective. X-rays revealed the patient¿s left quattrode was not fully inserted into the extension. To address the issue, the physician explanted and replaced the patient¿s extension on (b)(6) 2020. After changing the extension, one impedance on the right lead remained high, and the left side showed normal impedances. Postoperatively, effective stimulation was achieved. Note: it is unknown which quattrode serial number was affected, therefore both are being reported.

 
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Brand NameQUATTRODE LEAD, 3/6MM, 30 CM
Type of DeviceSCS LEAD
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 Key10382736
MDR Text Key202193787
Report Number1627487-2020-23246
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeSZ
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/31/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/28/2015
Device MODEL Number3153
Device Catalogue Number3153
Device LOT Number4046671
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 Received08/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/23/2013
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: 08/07/2020 Patient Sequence Number: 1
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