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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-1132
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Nerve Damage (1979)
Event Date 04/20/2018
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event: model #: sc-8336-70 serial #: (b)(4) description: coveredge 32, 70 cm 4x8 surgical lead model #: sc-4316 serial #: (b)(4) description: next generation anchor kit-sterile the explanted devices were not returned to bsn as they were kept by the medical facility.
 
Event Description
A report was received that the patient had a nerve damage aggravated by the ipg. The physician confirmed that it was not device related. The patient underwent an explant procedure.
 
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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 Key7523948
MDR Text Key108600432
Report Number3006630150-2018-01659
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 05/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/19/2018
Device Model NumberSC-1132
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 Received04/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2016
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: 05/17/2018 Patient Sequence Number: 1
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