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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-8216-70
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Visual Disturbances (2140); Numbness (2415)
Event Date 06/08/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional suspect medical device component involved in the event: model#: sc-1132, serial #: (b)(4), description: precision spectra implantable pulse generator. It is indicated that the device 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 during an exercise movement, the patient experienced an extreme sharp and sudden pain in his back. Since that time, the patient reported symptoms of tingling sensation in his hands and wrists, bottom of both feet and throughout both legs. The patient was also experiencing periodically blurring eye sight vision and weakness in hands, and stated that he had noticed dropping items from his hand from time to time. The physician does not know if the patient's symptoms are device related, and does not know the cause of the symptoms. The patient was scheduled to undergo a myelogram; ct scans of the cervical, thoracic and lumbar as well as a ct brain to rule out cerebrospinal fluid leak. The patient was also scheduled to undergo an electromyogram (emg) and nerve conduction test, but the patient passed away due to cardiac arrest. Therefore, these tests were never performed and no further information can be provided.
 
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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 Key5963894
MDR Text Key55161886
Report Number3006630150-2016-02673
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 06/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2012
Device Model NumberSC-8216-70
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 Received06/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/23/2010
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: 09/20/2016 Patient Sequence Number: 1
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