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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 Problem Hemorrhage/Bleeding (1888)
Event Date 08/16/2021
Event Type  Injury  
Manufacturer Narrative
Event date approximated based on the date the manufacturer became aware of the event.
 
Event Description
It was reported that during a trial procedure, the physician noted a bit of bleeding at the patients needle site.The trial procedure was aborted.The trial lead will not be returned.
 
Event Description
It was reported that during a trial procedure, the physician noted a bit of bleeding at the patients needle site.The trial procedure was aborted.The trial lead will not be returned.Additional information was received that the patient was doing well postoperatively.
 
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Brand Name
INFINION 16
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key12422564
MDR Text Key269800362
Report Number3006630150-2021-04948
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729797807
UDI-Public08714729797807
Combination Product (y/n)N
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/05/2023
Device Model NumberSC-2316-50E
Device Catalogue NumberSC-2316-50E
Device Lot Number7131855
Was Device Available for Evaluation? No
Date Manufacturer Received08/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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