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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEVRO CORP. SENZA NEVRO SENZA

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NEVRO CORP. SENZA NEVRO SENZA Back to Search Results
Model Number TLEAD1058-50B
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2017
Event Type  malfunction  
Manufacturer Narrative
The device was explanted, but was not returned for analysis. The manufacturing records were reviewed and no nonconformities were found.
 
Event Description
It was reported to nevro that a patient presented to the clinic for a lead removal at the end of a trial procedure. Both leads were explanted; however, the top contact was detached from each lead. The patient experienced good pain relief during the trial and is moving forward with a permanent implant. There were no reports of further complications.
 
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Brand NameSENZA
Type of DeviceNEVRO SENZA
Manufacturer (Section D)
NEVRO CORP.
1800 bridge parkway
redwood city CA 94065
Manufacturer Contact
rey nossa
1800 bridge parkway
redwood city, CA 94065
6504332742
MDR Report Key7153162
MDR Text Key96126965
Report Number3008514029-2017-00372
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2020
Device Model NumberTLEAD1058-50B
Device Catalogue NumberTLEAD1058-50B
Device Lot Number94407573
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/14/2017
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: 12/28/2017 Patient Sequence Number: 1
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