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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 Death (1802); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Septic Shock (2068)
Event Date 09/27/2018
Event Type  Death  
Manufacturer Narrative
Additional suspect medical device components involved: reference number: (b)(4), product family: scs-linear leads, upn: (b)(4), model: sc-2352-50, serial: (b)(4), batch: 21256334. Reference number: (b)(4), product family: scs-linear leads, upn: (b)(4), model: sc-2218-50, serial: (b)(4), batch: 5067154. Reference number: (b)(4), product family: scs-linear leads, upn: (b)(4), model: sc-2218-30, serial: (b)(4), batch: 5057353. Reference number: (b)(4), product family: scs-linear leads, upn: (b)(4), model: sc-2352-50, serial: (b)(4), batch: 5070438. A review of the manufacturing documentation for the explanted devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing. A review of the sterilization documentation for the explanted devices found them to be satisfactory. Device location is unknown.
 
Event Description
A patient was implanted on (b)(6) 2018 and was admitted for two days following surgery as part of standard protocol. The final wound check prior to discharge was unremarkable. On (b)(6) 2018 that patient died as an in patient in (b)(6) hospital in (b)(6), act due to septic shock, apparently secondary to infection of the ipg. Upon follow up with physician's assistant, the patient began experiencing pain in the right leg, approximately within the past 1-2 weeks prior to date of death. The patient checked into the emergency department of (b)(6) hospital on (b)(6) 2018 with pain in right leg, radiating to right low back at the ipg pocket site. The physician was notified of the patient's admission on (b)(6) 2018. Patient had an explant of the scs system on (b)(6) 2018 and died on (b)(6) 2018 due to sepsis.
 
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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 CLONMEL LIMITED
cashel road
,
clonmel
EI
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
,
valencia, CA 91355
6619494863
MDR Report Key7979795
MDR Text Key124163998
Report Number3006630150-2018-61422
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 10/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date11/27/2019
Device Model NumberSC-1132
Device Catalogue NumberSC-1132
Device Lot Number203732
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 Received09/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/27/2017
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: 10/18/2018 Patient Sequence Number: 1
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