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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI IPG STERILE KIT; SPINAL CORD STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI IPG STERILE KIT; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Fever (1858); Hematoma (1884); Sepsis (2067)
Event Date 04/11/2018
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event:  model: sc-2408-56 serial/lot: (b)(4) description: avista mri perc lead kit, 56 cm model: sc-4319 serial/lot: (b)(4) description: clik x mri anchor.
 
Event Description
A report was received that the patient was experiencing a fever, and pain in their lower back and right leg.The physician assessed the patient had an infection at the ipg pocket site and developed sepsis.It was also reported that a hematoma was aspirated at the pocket site.The patient was administered oral and i.V.Antibiotics.The patient underwent an explant procedure and was doing well post-operatively.The physician does not feel the infection was device or procedure related.
 
Event Description
A report was received that the patient was experiencing a fever, and pain in their lower back and right leg.The physician assessed the patient had an infection at the ipg pocket site and developed sepsis.It was also reported that a hematoma was aspirated at the pocket site.The patient was administered oral and i.V.Antibiotics.The patient underwent an explant procedure and was doing well post-operatively.The physician does not feel the infection was device or procedure related.
 
Manufacturer Narrative
Sc-1200 sn (b)(4): the device was explanted due to an infection in ipg pocket.The source of the infection was not determined.Residual gas analysis verified that the device insulation was not compromised.Review of the sterilization record did not find any anomalies or deviations that potentially relate to the reported event.Sc-2408-56 sn (b)(4); and sc-4319 lot 20733479: as the device involved in the complaint has not been returned, the complaint investigation site (cis) could not perform a device analysis.However, a review of the complaint report, device history record, and sterilization record were found to be satisfactory and did not find any anomalies or deviations that potentially relate to the reported event; there is no reason to suspect a manufacturing defect as the source of the reported complaint.
 
Event Description
A report was received that the patient was experiencing a fever, and pain in their lower back and right leg.The physician assessed the patient had an infection at the ipg pocket site and developed sepsis.It was also reported that a hematoma was aspirated at the pocket site.The patient was administered oral and i.V.Antibiotics.The patient underwent an explant procedure and was doing well post-operatively.The physician does not feel the infection was device or procedure related.
 
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Brand Name
PRECISION MONTAGE MRI IPG STERILE KIT
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 Key7492540
MDR Text Key107556878
Report Number3006630150-2018-01597
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729905943
UDI-Public08714729905943
Combination Product (y/n)N
Reporter Country CodeUK
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,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date08/04/2019
Device Model NumberSC-1200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2017
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) Required Intervention;
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