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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-2218-50E
Device Problem No Apparent Adverse Event (3189)
Patient Problems Inflammation (1932); Nerve Damage (1979); Numbness (2415)
Event Date 06/24/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional suspect medical device component involved in the event: model#: sc-2218-50e serial/lot#: (b)(4) description: trial linear st lead, 50cm model#: sc-2352-50e serial/lot#: (b)(4) description: trial linear 3-4 lead, 50cm the devices were not returned to bsn.
 
Event Description
A report was received that after a trial procedure, the patient was experiencing numbness and difficulty moving the left arm and leg. The physician believed that it was due to scar tissue and also though that running the leads during the procedure caused inflammation and irritation on some of the nerve roots thus causing the patient's symptoms. The physician performed an early lead pull and medrol dosepak was prescribed for inflammation. The physician did not suspect that the symptoms were device related. The patient was reportedly doing well.
 
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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 Key5800355
MDR Text Key49737512
Report Number3006630150-2016-01937
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
Report Date 06/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/09/2018
Device Model NumberSC-2218-50E
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 Received06/24/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/11/2016
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: 07/16/2016 Patient Sequence Number: 1
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