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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVECTRA CORPORATION ALGOVITA SPINAL CORD STIMULATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF)

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NUVECTRA CORPORATION ALGOVITA SPINAL CORD STIMULATION STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) Back to Search Results
Model Number 2408
Device Problem High impedance (1291)
Patient Problems Nausea (1970); Weakness (2145); Burning Sensation (2146); Dizziness (2194)
Event Date 02/13/2018
Event Type  Injury  
Event Description
It was reported to nuvectra that the patient experienced a burning sensation, tingling in the face, nausea, dizziness, and weakness due to the uncomfortable overstimulation. The device was re-programmed and all impedances are fine. The patient is doing well.
 
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Brand NameALGOVITA SPINAL CORD STIMULATION
Type of DeviceSTIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF)
Manufacturer (Section D)
NUVECTRA CORPORATION
10675 naples street ne
blaine MN 55449
Manufacturer (Section G)
NUVECTRA CORPORATION
10675 naples street ne
blaine MN 55449
Manufacturer Contact
david douglas
10675 naples street ne
blaine, MN 55449
7634047531
MDR Report Key7302784
MDR Text Key101157016
Report Number3010309840-2018-00064
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P130028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/22/2018
Device Model Number2408
Device Catalogue Number2408
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/28/2018 Patient Sequence Number: 1
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