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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-6412-3
Device Problems Failure to Charge (1085); Overheating of Device (1437); Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn(s) (1757)
Event Date 07/20/2020
Event Type  Injury  
Event Description
It was reported that the patient had to charge the ipg frequently.This resulted to the charger heating up and burning the patient.It was also reported that the overheating of the unit resulted to wound disruption and infection (mfr report number: 3006630150-2021-00347).
 
Manufacturer Narrative
Sc-6412-3 sn: (b)(6).The returned charger was analyzed and was able to fully charge a depleted known good ipg to 4v in one four hours cycle and the double beep was produced once the ipg was fully charged.The maximum temperature reached during the charging time was 38.69 degrees celsius.This was below the 42 degrees celsius limit.The associated accessories (base station and power supply) exhibited normal characteristics during the visual and functional examination.With all the available information, boston scientific concludes that the reported event was not confirmed.
 
Event Description
It was reported that the patient had to charge the ipg frequently.This resulted to the charger heating up and burning the patient.It was also reported that the overheating of the unit resulted to wound disruption and infection (mfr report number: 3006630150-2021-00347).
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112 5798
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key11310169
MDR Text Key231304979
Report Number3006630150-2021-00371
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729821243
UDI-Public08714729821243
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberSC-6412-3
Device Catalogue NumberSC-6412-3
Device Lot Number372960
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/14/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient SexFemale
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