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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-2316-50E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Nerve Damage (1979); Pain (1994); Paralysis (1997); Weakness (2145)
Event Date 03/08/2018
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device component involved in the event: model#: sc-2316-50e, serial #: (b)(4).Description: infinion 1x16 perc lead and splitter 2x8 kits.
 
Event Description
A report was received that the patient had an epidural hematoma after the trial leads were removed.It was noted that the patient was sent to hospital due to inability to move her right leg, quad weakness and complained of severe leg pain.The physician believed that scs trial procedure caused the patients symptoms.No further information could be obtained.
 
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Brand Name
PRECISION SPECTRA
Type of Device
SPINAL 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 Key7379457
MDR Text Key103750446
Report Number3006630150-2018-01171
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729797807
UDI-Public08714729797807
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 Physician
Type of Report Initial
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/29/2020
Device Model NumberSC-2316-50E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/08/2018
Initial Date FDA Received03/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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