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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 1121-60
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/25/2019
Event Type  Injury  
Event Description
It was reported to nuvectra that the stimulator and percutaneous lead were explanted prior to the patient receiving an mri. Patient is to receive a paddle lead implant as there was no issue with the device/therapy.
 
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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 Key8541168
MDR Text Key142811217
Report Number3010309840-2019-00192
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/26/2019
Device Model Number1121-60
Device Catalogue Number1121-60
Device Lot NumberW4092889
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/26/2017
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: 04/23/2019 Patient Sequence Number: 1
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