PRECISION SC-1110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for PRECISION SC-1110 manufactured by Boston Scientific Neuromodulation.

Event Text Entries

[185983688] Model number/catalog number: sc-1110, serial number: (b)(4), batch/lot number: 802543, model/catalog description: scs ipg2 dual array rechargable ipg. The explanted device was not returned to bsn.
Patient Sequence No: 1, Text Type: N, H10


[185983689] A report was received that the patient was experiencing frequent ipg charging and fast battery depletion. The patient underwent an ipg replacement procedure and was doing well postoperatively.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006630150-2020-01570
MDR Report Key9908745
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2016-03-25
Date Mfgr Received2020-03-11
Device Manufacturer Date2005-07-09
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTALAR TAHMASIAN
Manufacturer Street25155 RYE CANYON LOOP
Manufacturer CityVALENCIA CA 91355
Manufacturer CountryUS
Manufacturer Postal91355
Manufacturer Phone6619494863
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer Street25155 RYE CANYON LOOP
Manufacturer CityVALENCIA CA 91355
Manufacturer CountryUS
Manufacturer Postal Code91355
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRECISION
Generic NameSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Product CodeLGW
Date Received2020-03-31
Model NumberSC-1110
Catalog NumberSC-1110
Lot Number701756
Device Expiration Date2005-12-30
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC NEUROMODULATION
Manufacturer Address25155 RYE CANYON LOOP VALENCIA CA 91355 US 91355


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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