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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION NOVI SPINAL CORD STIMULATOR

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION NOVI SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1140
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Discomfort (2330); Reaction (2414)
Event Date 03/29/2017
Event Type  Injury  
Manufacturer Narrative
A review of the sterilization documentation for the devices were found to be satisfactory.
 
Event Description
A report was received that the patient developed an unpleasant feeling at the ipg pocket site. The patient will undergo a revision or explant procedure.
 
Event Description
A report was received that the patient developed an unpleasant feeling at the ipg pocket site. The patient will undergo a revision or explant procedure.
 
Manufacturer Narrative
A report was received that the patient underwent an explant procedure wherein all of the patient's devices were removed due to suspected allergic reaction. No device malfunction was suspected. It is unknown if the allergy is device related, however, the physician stated it seems clear that there was no infection. Additional suspect medical device components involved in the event: model #: sc-2366-70 lot #: 3090237 description: linear 3-6 lead, 70cm model #: sc-4316 lot #: 19765827 description: next generation anchor kit-sterile the explanted devices were not returned to bsn.
 
Event Description
A report was received that the patient developed an unpleasant feeling at the ipg pocket site. The patient will undergo a revision or explant procedure.
 
Manufacturer Narrative
As the devices involved in the complaint have not been returned, the complaint investigation site (cis) could not perform device analysis. However a review of the complaint report and device history record did not find any anomalies or deviations that potentially relate to the reported event; there is no reason to suspect a manufacturing defect as the source of the reported complaint.
 
Event Description
A report was received that the patient developed an unpleasant feeling at the ipg pocket site. The patient will undergo a revision or explant procedure.
 
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Brand NamePRECISION NOVI
Type of DeviceSPINAL CORD STIMULATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key6501549
MDR Text Key108189998
Report Number3006630150-2017-01493
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/07/2018
Device Model NumberSC-1140
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 Received08/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2016
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: 04/18/2017 Patient Sequence Number: 1
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