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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 2412
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 08/08/2018
Event Type  Injury  
Event Description
It was reported to nuvectra that the patient experienced an infection, two months post permanent implant due to an unknown reason. Subsequently, the stimulator and leads were explanted.
 
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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 Key7855691
MDR Text Key119557000
Report Number3010309840-2018-00104
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 09/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/12/2020
Device Model Number2412
Device Catalogue Number2412
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 Received08/09/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/12/2018
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: 09/07/2018 Patient Sequence Number: 1
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