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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUALITY TECH SERVICES LLC NEXDRIVE INSTRUMENT, STEREOTAXIC

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QUALITY TECH SERVICES LLC NEXDRIVE INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number MI-2000
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/30/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received by a healthcare professional (hcp) regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that during implant, the hcp was using the nexframe and when the cannula was placed in the medial/right entry, it was very tight. There was no out of box failure reported. No symptoms were reported. No further complications were reported/anticipated.
 
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Brand NameNEXDRIVE
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
QUALITY TECH SERVICES LLC
7842 hickory flat highway
suite d
woodstock GA 30188
Manufacturer (Section G)
QUALITY TECH SERVICES LLC
7842 hickory flat highway
suite d
woodstock GA 30188
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9560282
MDR Text Key175196407
Report Number3012165443-2020-00001
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/25/2020
Device Model NumberMI-2000
Device Catalogue NumberMI-2000
Device Lot Number082629819
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 Received01/23/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/04/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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