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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION MULTIWAVE SPINAL CORD STIMULATOR

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION MULTIWAVE SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1112
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Fever (1858); Sepsis (2067); Swelling (2091)
Event Date 12/21/2017
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event: model: sc-2352-70 serial/lot: (b)(4) description: linear 3-4 lead, 70cm model: sc-4318 serial/lot: (b)(4) descripcription: clik x anchor 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 dizziness, fever and a swollen face. The physician assessed that the patient had a non-device related infection and sepsis in the blood. The patient was hospitalized and was assessed to be in serious condition. The patient was administered antibiotics and an explant of the entire system was conducted.
 
Manufacturer Narrative
The explanted devices were not returned to bsn as they were discarded by the medical facility. The model number and serial numbers of the explanted lead or leads is currently unknown.
 
Event Description
A report was received that the patient was experiencing dizziness, fever and a swollen face. The physician assessed that the patient had a non-device related infection and sepsis in the blood. The patient was hospitalized and was assessed to be in serious condition. The patient was administered antibiotics and an explant of the entire system was conducted.
 
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Brand NamePRECISION MULTIWAVE
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 Key7216966
MDR Text Key107369164
Report Number3006630150-2018-00333
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/24/2018
Device Model NumberSC-1112
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 Received02/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2016
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: 01/24/2018 Patient Sequence Number: 1
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