INFINION 16 SC-2316-70

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for INFINION 16 SC-2316-70 manufactured by Boston Scientific Neuromodulation.

Event Text Entries

[185915380] Additional suspect medical device components involved in the event: model: sc-2316-70. Serial/lot: (b)(4). Description: infinion 16 lead kit 70 cm.
Patient Sequence No: 1, Text Type: N, H10


[185915381] A report was received that the patient underwent a lead revision procedure wherein the leads were replaced. The patient had experienced inadequate pain coverage and high impedances were observed. Programming was unsuccessful in covering pain areas. The explanted leads were discarded by the hospital. The patient is recovering.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006630150-2020-01561
MDR Report Key9908173
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-11-01
Date Mfgr Received2020-03-19
Device Manufacturer Date2016-05-09
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 NameINFINION 16
Generic NameSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Product CodeLGW
Date Received2020-03-31
Model NumberSC-2316-70
Catalog NumberSC-2316-70
Lot Number19217414
Device Expiration Date2018-05-09
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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