ERA 3000 DE/EN 128828 SEE MODEL NO.

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-07-14 for ERA 3000 DE/EN 128828 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.

Event Text Entries

[6056885] Ous mdr - it was reported that an asystole occurred during the implantation of a pacemaker in a pacemaker-dependent patient while the lead was being connected. Pacing via this era 3000 was not possible. Resuscitation via cardiac massaging was necessary. The external device was returned to biotronik for analysis.
Patient Sequence No: 1, Text Type: D, B5


[46375265] The returned pacing threshold measurement device, including three batteries, was thoroughly analyzed. The device showed damage and missing parts at the housing. Further analysis showed that the power supply and pacemaker circuit boards were severely damaged. Based on the kind of damage, it can be assumed that the device was damaged during the described external defibrillation, so that the original trigger for the clinical observation could no longer be determined. In addition, the batteries were examined. The sn (b)(4) was defect, the two other batteries did not show any deviations.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1028232-2015-02515
MDR Report Key4911827
Report Source*
Date Received2015-07-14
Date of Report2015-07-02
Date of Event2015-06-08
Date Mfgr Received2016-05-25
Device Manufacturer Date2006-09-14
Date Added to Maude2015-07-14
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 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 NameERA 3000 DE/EN
Generic NamePACING SYSTEM ANALYZER
Product CodeDTA
Date Received2015-07-14
Model Number128828
Catalog NumberSEE MODEL NO.
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBIOTRONIK SE & CO. KG
Manufacturer AddressWOERMANNKEHRE 1 BERLIN D-12359 GM D-12359


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2015-07-14

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