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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 Problems Bacterial Infection (1735); Edema (1820); Hematoma (1884); Impaired Healing (2378)
Event Date 11/08/2016
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event: model #: sc-2316-50, serial #: (b)(4), description: infinion 1x16 perc lead kit-50 cm. Model #: sc-3400-30, serial #: infinion splitter 2x8 kit (30 cm) description: (b)(4). The explanted devices were not returned to bsn. It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices 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 was experiencing infection at the pocket site. Symptoms were swelling, hematoma, and healing impairment. The patient was placed on antibiotics and underwent an explant procedure. The physician believed that the infection was device related.
 
Manufacturer Narrative
Additional information was received that the patient was not healing well. The physician did not know the cause of the hematoma, but it was located in the pocket site. It was believed that the patient's hematoma was not device related.
 
Event Description
A report was received that the patient was experiencing infection at the pocket site. Symptoms were swelling, hematoma, and healing impairment. The patient was placed on antibiotics and underwent an explant procedure. The physician believed that the infection was device related.
 
Manufacturer Narrative
Additional information was received that no further information could be obtained.
 
Event Description
A report was received that the patient was experiencing infection at the pocket site. Symptoms were swelling, hematoma, and healing impairment. The patient was placed on antibiotics and underwent an explant procedure. The physician believed that the infection was device related.
 
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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 Key6146831
MDR Text Key61490861
Report Number3006630150-2016-03527
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 11/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/28/2018
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 Received12/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2016
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: 12/06/2016 Patient Sequence Number: 1
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