ACTICOR 7 DR-T DF4 PROMRI 429524 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 2020-03-23 for ACTICOR 7 DR-T DF4 PROMRI 429524 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.

Event Text Entries

[184536410] An infection was observed following the implantation of this biotronik device. The sterilization process was investigated. The validated process assures that all sterilization parameters, such as gas concentration, temperature, humidity, etc. , are within its specified ranges for each distributed device. Additionally an analysis of validated microbiological indicators is performed after every sterilization procedure as evidence of successful completion of the sterilization process. Review of the biotronik complaint database did not reveal any changes regarding the trend for this type of incident. In conclusion, the infection was not device related.
Patient Sequence No: 1, Text Type: N, H10


[184536411] It was noted that there was redness and swelling at the pocket area. The acticor and leads were all removed due to possibility of infection.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1028232-2020-01400
MDR Report Key9866864
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-03-18
Date Mfgr Received2020-03-23
Device Manufacturer Date2019-10-21
Date Added to Maude2020-03-23
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 NameACTICOR 7 DR-T DF4 PROMRI
Generic NameICD
Product CodeMRM
Date Received2020-03-23
Model Number429524
Catalog NumberSEE MODEL NO.
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOTRONIK SE & CO. KG
Manufacturer AddressWOERMANNKEHRE 1 BERLIN 12359 DE 12359


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-03-23

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