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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1200
Device Problem Material Separation (1562)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 03/21/2018
Event Type  Injury  
Manufacturer Narrative
Device evaluation indicated that the complaint was confirmed. The setscrew from port c was missing. It was reported that the setscrew fell out of ipg in the operation room when the tech was trying to lessen for port plug. The device functionality test was performed to ensure the device integrity. No other anomalies were found.
 
Event Description
A report was received that the product was return due to a setscrew fell out of ipg while the tech was trying to lessen for port plug. It was unknown if the missing setscrew was removed or left inside the patient's body.
 
Manufacturer Narrative
Additional information was received that the setscrew fell on the ground and was never near the patient's body.
 
Event Description
A report was received that the product was returned due to a setscrew fell out of ipg while the tech was trying to lessen for port plug. It was unknown if the missing setscrew was removed or left inside the patient's body.
 
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Brand NamePRECISION MONTAGE MRI
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 Key7432960
MDR Text Key105557464
Report Number3006630150-2018-01203
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
030017
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 05/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/13/2019
Device Model NumberSC-1200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2017
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: 04/16/2018 Patient Sequence Number: 1
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