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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1112
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Nausea (1970); Complaint, Ill-Defined (2331); Patient Problem/Medical Problem (2688)
Event Date 06/06/2018
Event Type  Injury  
Event Description
A report was received that the patient underwent two separate implant procedures. The patient underwent a lead implant procedure and then an ipg implant procedure. After the ipg implant procedure, the patient developed a migraine-like headache and nausea, which was moderate in severity. The patient was treated with medication and the event was resolved. The physician noted that the issue was related to the surgical procedure and not related to the device system.
 
Event Description
A report was received that the patient underwent two separate implant procedures. The patient underwent a lead implant procedure and then an ipg implant procedure. After the ipg implant procedure, the patient developed a migraine-like headache and nausea, which was moderate in severity. The patient was treated with medication and the event was resolved. The physician noted that the issue was related to the surgical procedure and not related to the device system.
 
Manufacturer Narrative
A review of the manufacturing documentation for the sc-1112 (serial number: (b)(4)) revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
 
Event Description
A report was received that the patient underwent two separate implant procedures. The patient underwent a lead implant procedure and then an ipg implant procedure. After the ipg implant procedure, the patient developed a migraine-like headache and nausea, which was moderate in severity. The patient was treated with medication and the event was resolved. The physician noted that the issue was related to the surgical procedure and not related to the device system.
 
Manufacturer Narrative
Additional information was received that the patient developed migraine-like headache and nausea, which was mild in severity. The physician assessed that the event was not related to the device system.
 
Event Description
A report was received that the patient underwent two separate implant procedures. The patient underwent a lead implant procedure and then an ipg implant procedure. After the ipg implant procedure, the patient developed a migraine-like headache and nausea, which was moderate in severity. The patient was treated with medication and the event was resolved. The physician noted that the issue was related to the surgical procedure and not related to the device system.
 
Manufacturer Narrative
Additional information was received that the event was related to the device system. Amendment: adverse event/product problem.
 
Event Description
A report was received that the patient underwent two separate implant procedures. The patient underwent a lead implant procedure and then an ipg implant procedure. After the ipg implant procedure, the patient developed a migraine-like headache and nausea, which was moderate in severity. The patient was treated with medication and the event was resolved. The physician noted that the issue was related to the surgical procedure and not related to the device system.
 
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Brand NamePRECISION
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 NEUROMODULATION CORPORATION
25129 rye canyon loop
,
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
,
valencia, CA 91355
6619494863
MDR Report Key7716475
MDR Text Key114930552
Report Number3006630150-2018-60328
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P030017
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,Followup
Report Date 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Model NumberSC-1112
Device Catalogue NumberSC-1112
Device Lot Number20463818
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 Received06/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2017
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: 07/24/2018 Patient Sequence Number: 1
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