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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 09/15/2016
Event Type  Injury  
Manufacturer Narrative
A device history record review was conducted. Process monitoring for sterile package seal strength was acceptable, pyrogen monitoring was acceptable and the standard sterilization cycle was achieved with passing biological indicator results. No anomalies were noted. (b)(4). Device not returned to manufacturer.
 
Event Description
The patient developed a severe infection at the electrode site less than 1 month post implant. A full system explant was performed on (b)(6) 2016. As of (b)(6) 2016, the patient was doing well.
 
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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
anne reali
10675 naples avenue ne
blaine, MN 55449
7634047508
MDR Report Key6139978
MDR Text Key61290374
Report Number3010309840-2016-00011
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
Reporter Occupation
Type of Report Initial
Report Date 09/15/2016
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 Model Number2412
Device Catalogue Number2412
Device Lot NumberW3432565
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 Received09/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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