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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-8336-50
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Paralysis (1997)
Event Date 12/11/2017
Event Type  Injury  
Manufacturer Narrative
Additional information was received that the cause of hematoma was unknown. No device malfunction was suspected.
 
Event Description
A report was received that the patient had a hematoma after the implant procedure. The patient underwent an explant procedure wherein only the lead was removed.
 
Manufacturer Narrative
A additional information was received that the onset of the patients symptoms was about three hours following the procedure. It was noted that the patient developed a blood clot the length of her spine and was admitted to the intensive care unit (icu). The patient lost mobility in her arms and legs, and was referred to transitional care for rehabilitation. The patient is assessed as fine. It is indicated that the paddle lead will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. A review of the device history records will be conducted. If there is any further relevant information from that review, a supplemental med watch will be filed.
 
Event Description
A report was received that the patient had a hematoma after the implant procedure. The patient underwent an explant procedure wherein only the lead was removed.
 
Manufacturer Narrative
The explanted device was not returned to bsn as it was discarded by the medical facility.
 
Event Description
A report was received that the patient had a hematoma after the implant procedure. The patient underwent an explant procedure wherein only the lead was removed.
 
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Brand NamePRECISION SPECTRA
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 Key7153053
MDR Text Key107741225
Report Number3006630150-2017-05313
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,Followup
Report Date 02/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/26/2019
Device Model NumberSC-8336-50
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 Received02/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/30/2017
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: 12/28/2017 Patient Sequence Number: 1
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