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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2316-50E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); No Code Available (3191)
Event Date 12/09/2019
Event Type  Injury  
Manufacturer Narrative
Model number/catalog number: sc-2316-50e, serial number: (b)(4), batch/lot number: 5150468, model/catalog description: infinion 16 trial lead kit 50 cm. It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint device 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 medwatch will be filed.
 
Event Description
A report was received that the patient had an excessive bleeding at the entry site of the trial lead. The leads were removed and the patients bleeding was controlled.
 
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Brand NameINFINION 16
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
road 698, lot no. 12
dorado PR 00646 -260
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key9529029
MDR Text Key173163893
Report Number3006630150-2019-07728
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/20/2021
Device Model NumberSC-2316-50E
Device Catalogue NumberSC-2316-50E
Device Lot Number5148053
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 Received12/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2019
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: 12/30/2019 Patient Sequence Number: 1
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