REOCOR D 365529 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 2015-05-05 for REOCOR D 365529 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.

Event Text Entries

[5826010] Ous mdr - the clinic states that their biomedical maintenance service identified a loss of sensing on the last four devices (external pacemakers) acquired in (b)(4) 2014. They felt that "the pacemaker should beep continuously if the impedance is equal or greater than 10,000 ohms or if the impedance is equal or less than 50 ohms, but these 4 devices did not respond in the tests performed at equal or below 50 ohms. This loss of response was not observed with similar devices of the older generation. " there were no patient interactions when these tests were being performed.
Patient Sequence No: 1, Text Type: D, B5


[13328977] We received your event description for the above mentioned devices and the observation of the clinical user can be retraced in our quality and production documentation of the device. The observations are correct and according to the expected device behavior. The described missing alarm is no deviation of the device specification. During market observations in the past distracting and unnecessary false alarms due to low impedances were stated. The cause might be too close placed heart wires or the use of low resistive wires of different manufacturers. The alarm for the low impedance of reocur was therefore considered too sensitive and was deactivated. The risk assessment, as well as the user manual, was adapted accordingly. However, high impedances might be critical for the patient for instance by accidently disconnecting the external pacemaker. Thus the warning threshold for high impedances stays unmodified. As of today, the medical device is not available for analysis; therefore, the device itself could not be investigated. Should additional relevant information or the device itself become available, the investigation will be updated.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1028232-2015-01472
MDR Report Key4748444
Report Source*
Date Received2015-05-05
Date of Report2015-04-24
Date Mfgr Received2015-04-24
Device Manufacturer Date2013-10-11
Date Added to Maude2015-05-05
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 FDA0
Event Location0
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 NameREOCOR D
Generic NameEXTERNAL PACEMAKER
Product CodeOVJ
Date Received2015-05-05
Model Number365529
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 D-12359 GM D-12359


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-05-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.