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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 NIPG1500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Swelling (2091); Patient Problem/Medical Problem (2688)
Event Date 08/02/2016
Event Type  Injury  
Manufacturer Narrative
Nevro had been trying to obtain additional information regarding the details of this case.Nevro is awaiting for the patient's appointment with the physician.
 
Event Description
During a follow up call, patient informed nevro that after the implant procedure, upon review of the x-rays, physician had stated that the leads were placed incorrectly.The patient was hospitalized for a few days after the implant procedure for swelling, difficulty in breathing and urinating, among other symptoms.The patient was advised to turn off the stimulation.Stimulation was turned back on later.The patient was discharged from the hospital and resumed normal activities.The patient declined to state current status.
 
Manufacturer Narrative
The device has not been explanted.Nevro had been following up with the patient and was informed that the patient's treating physician has left the practice.At this time, the stimulation is off and the patient is managing the chronic pain with medications.The reported issues had not recurred with stimulation off.Currently, there is no additional information regarding the patient's conditions until the patient finds a new pain physician and obtain insurance approval.
 
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Brand Name
SENZA
Type of Device
NEVRO 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 Key6421090
MDR Text Key70458270
Report Number3008514029-2017-00047
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00813426020015
UDI-Public00813426020015
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 Other
Type of Report Initial,Followup
Report Date 07/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date03/01/2018
Device Model NumberNIPG1500
Device Catalogue NumberNIPG1500
Device Lot Number9437104
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/23/2017
Initial Date FDA Received03/21/2017
Supplement Dates Manufacturer Received02/23/2017
Supplement Dates FDA Received07/18/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age37 YR
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