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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION NOVI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION NOVI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1140
Device Problems Unexpected Therapeutic Results (1631); Battery Problem (2885)
Patient Problem Inadequate Pain Relief (2388)
Event Date 07/12/2022
Event Type  Injury  
Manufacturer Narrative
Date of event: approximated based on the date the manufacturer became aware of the event.
 
Event Description
It was reported that the patient was experiencing inadequate stimulation. It was also noted that the ipg is at its end of life. The patient underwent an ipg replacement procedure and was doing well postoperatively.
 
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Brand NamePRECISION NOVI
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key15153837
MDR Text Key297131374
Report Number3006630150-2022-03801
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729897835
UDI-Public08714729897835
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/25/2019
Device Model NumberSC-1140
Device Catalogue NumberSC-1140
Device Lot Number21049670
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2017
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: 08/02/2022 Patient Sequence Number: 1
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