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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVECTRA CORPORATION NUVECTRA CORPORATION; STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF)
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NUVECTRA CORPORATION NUVECTRA CORPORATION; STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) Back to Search Results
Model Number 1124-60
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/27/2019
Event Type  malfunction  
Event Description
It was reported to nuvectra that during a permanent lead implant, the physician experienced difficulty inserting the stylet into the lead.A different stylet was used and met with resistance with no success.The stylet protruded through the distal end of the lead.A replacement lead was used.
 
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Brand Name
NUVECTRA CORPORATION
Type of Device
STIMULATOR, 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
david douglas
10675 naples street ne
blaine, MN 55449
7634047531
MDR Report Key8832809
MDR Text Key167983418
Report Number3010309840-2019-00226
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 Physician
Type of Report Initial
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/02/2021
Device Model Number1124-60
Device Catalogue Number1124-60
Device Lot NumberW4804041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/27/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/02/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age30 YR
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