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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-5312
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 08/01/2020
Event Type  Injury  
Manufacturer Narrative
Exact date unknown, event occurred in the last couple of months.
 
Event Description
It was reported that the patient was burned twice over the last couple of months.
 
Manufacturer Narrative
Block d4: 12/31/9999.
 
Event Description
It was reported that the patient was burned twice over the last couple of months.Additional information was received that the first burn incident was last august 2020 when the patient got the new charger.It was stated that the site had blisters and it occurred while charging the ipg located on the patients back for an hour.The second burn incident occurred last november 2020 and it was not as severe as the first burn and it did not fully blister.It was stated that the patient charged for thirty minutes and felt it getting warm.
 
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Brand Name
PRECISION
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 Key11320922
MDR Text Key231576425
Report Number3006630150-2021-00447
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 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberSC-5312
Device Catalogue NumberSC-5312
Device Lot Number377804
Was Device Available for Evaluation? No
Date Manufacturer Received03/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
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