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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1132
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Inflammation (1932); Fluid Discharge (2686); No Code Available (3191)
Event Date 03/03/2020
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event: model: sc-2218-70, serial/ lot: (b)(4), description: linear st lead kit 70 cm. Model: sc-2218-50, serial/ lot: (b)(4), description: linear st lead kit 50 cm. Model: sc-2218-50, serial/ lot: (b)(4), description: linear st lead kit 50 cm.
 
Event Description
It was reported that the patient had an infection and the patients system was explanted. Devices will not be returned as they were disposed by the facility. The physician assessed that the infection was located at the lead and ipg site. The patient had symptoms of inflammation and fluid discharge. A culture was performed and the patient was treated with antibiotics, results are unknown.
 
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Brand NamePRECISION SPECTRA
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key9931357
MDR Text Key186716923
Report Number3006630150-2020-01665
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/17/2020
Device Model NumberSC-1132
Device Catalogue NumberSC-1132
Device Lot Number206363
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 Received05/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/18/2018
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: 04/06/2020 Patient Sequence Number: 1
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