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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-2317-70
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Death (1802); Purulent Discharge (1812); Sepsis (2067)
Event Date 12/16/2017
Event Type  Death  
Manufacturer Narrative
Additional suspect medical device components involved in the event: model # sc-2317-70, serial/lot # (b)(4), description: infinion tm cx 70 cm lead.Model # sc-1132, serial/lot # (b)(4), description: precision spectra implantable pulse generator.
 
Event Description
A report was received that the patient was hospitalized 2 weeks post implant due to suspected infection at the midline incision.The patient complained of not feeling well.The patients wounds were checked and revealed one site having surface area oozing, with no significant pus at the incision sites.Both incision sites were cleaned, new dressings were placed and antibiotics were administered.The patient became very unwell in the next 48 hours and was transferred to another facility.She was explanted, intubated and required medication to stabilize her blood pressure.There is no evidence to suggest the infection was device or procedure related.The physician assessed the patient to have critical condition sepsis and he does not expect the patient to survive.
 
Manufacturer Narrative
Additional information was received that the patient passed away due to multiple organ failure due to sepsis.The explanted devices were not returned to bsn as they were discarded by the medical facility.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the devices was found to be satisfactory.
 
Event Description
A report was received that the patient was hospitalized 2 weeks post implant due to suspected infection at the midline incision.The patient complained of not feeling well.The patients wounds were checked and revealed one site having surface area oozing, with no significant pus at the incision sites.Both incision sites were cleaned, new dressings were placed and antibiotics were administered.The patient became very unwell in the next 48 hours and was transferred to another facility.She was explanted, intubated and required medication to stabilize her blood pressure.There is no evidence to suggest the infection was device or procedure related.The physician assessed the patient to have critical condition sepsis and he does not expect the patient to survive.
 
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Brand Name
PRECISION SPECTRA
Type of Device
SPINAL 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 Key7139878
MDR Text Key95547800
Report Number3006630150-2017-05403
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729861638
UDI-Public08714729861638
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/29/2019
Device Model NumberSC-2317-70
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/05/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Life Threatening; Required Intervention;
Patient Age72 YR
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