LINOX SMART PROMRI S 65 377166 SEE MODEL NO.

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 2019-11-26 for LINOX SMART PROMRI S 65 377166 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.

Event Text Entries

[168297990] After an implantation period of approx. 80 months, oversensing in the ventricular channel was reported. The hospital suspects damage to the lead.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1028232-2019-05235
MDR Report Key9379591
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-26
Date of Report2019-11-07
Date of Event2019-10-22
Date Mfgr Received2019-11-26
Device Manufacturer Date2012-12-10
Date Added to Maude2019-11-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street6024 JEAN ROAD
Manufacturer CityLAKE OSWEGO OR 97035
Manufacturer CountryUS
Manufacturer Postal97035
Manufacturer Phone8772459800
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLINOX SMART PROMRI S 65
Generic NameICD LEAD
Product CodeNVY
Date Received2019-11-26
Returned To Mfg2019-11-15
Model Number377166
Catalog NumberSEE MODEL NO.
Device Expiration Date2014-12-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBIOTRONIK SE & CO. KG
Manufacturer AddressWOERMANNKEHRE 1 BERLIN 12359 12359


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-11-26

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