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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 1124-75
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Skin Erosion (2075)
Event Date 09/30/2017
Event Type  Injury  
Event Description
It was reported to nuvectra that a revision was performed due to one of the leads poking through the patient's skin. The leads were re-positioned and the patient is receiving adequate coverage.
 
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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
bob shokoohi
10675 naples street ne
blaine, MN 55449
7634047512
MDR Report Key6981292
MDR Text Key90394395
Report Number3010309840-2017-00042
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 10/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/01/2018
Device Model Number1124-75
Device Catalogue Number1124-75
Device Lot NumberW3870703
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/30/2017
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

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