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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Injury (2348)
Event Date 01/21/2016
Event Type  Injury  
Manufacturer Narrative
Device will not be returned to manufacturer for evaluation. A review of the device history record (dhr) is pending. Nuvectra is not able to submit this mdr due to issues with the portal set up process ((b)(4)) device not returned.
 
Event Description
Patient developed an infection 2 months post implant. The system was explanted. A new system was implanted and the patient is doing fine.
 
Manufacturer Narrative
Initial: device will not be returned to manufacturer for evaluation. A review of the device history record (dhr) is pending. Nuvectra is not able to submit this mdr due to issues with the portal set up process (ticket #s (b)(4)) follow-up/final: the source of the infection was not specified. The root cause for this event could not be determined as no device was returned for evaluation and review of the manufacturing records did not reveal any applicable discrepancies. No malfunction of the device could be confirmed. Device not returned.
 
Event Description
Patient developed an infection 2 months post implant. The system was explanted. A new system was implanted and the patient is doing fine.
 
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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 me
blaine MN 55449
Manufacturer Contact
amy parker
10675 naples street ne
blaine, MN 55449
7634047531
MDR Report Key6139851
MDR Text Key61291510
Report Number3010309840-2016-00012
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P130028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/08/2017
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 Received09/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2015
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: 12/01/2016 Patient Sequence Number: 1
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