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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 No Known Impact Or Consequence To Patient (2692)
Event Date 09/12/2017
Event Type  malfunction  
Event Description
It was reported to nuvectra that during implant of a permanent lead, the stylet protruded through the distal end of the lead. The lead was replaced and the patient is receiving adequate coverage. No patient harm was reported.
 
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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 Key6929805
MDR Text Key90159019
Report Number3010309840-2017-00038
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 10/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/08/2019
Device Model Number1124-75
Device Catalogue Number1124-75
Device Lot NumberW3753060
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/12/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/08/2017
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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