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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 Pain (1994); Burning Sensation (2146)
Event Date 06/11/2021
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: m365sc231650e0, model: sc-2316-50e, serial: ni, batch: ni.
 
Event Description
It was reported that right after the patient was awake after the trial procedure, the patient was experiencing pain and burning sensation.The patient was given medication to treat the pain.The patient was doing better.
 
Event Description
It was reported that right after the patient was awake after the trial procedure, the patient was experiencing pain and burning sensation.The patient was given medication to treat the pain.The patient was doing better.Additional information was received that the cause of the patients pain was unknown and the physician was uncertain that the pain was device related.The patients trial leads were explanted and were discarded by the facility.
 
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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 Key12103736
MDR Text Key259599919
Report Number3006630150-2021-03414
Device Sequence Number1
Product Code LGW
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 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date05/12/2023
Device Model NumberSC-2316-50E
Device Catalogue NumberSC-2316-50E
Device Lot Number7126578
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/11/2021
Initial Date FDA Received07/01/2021
Supplement Dates Manufacturer Received07/02/2021
Supplement Dates FDA Received07/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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