MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-08-06 for REOCOR D 365529 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[4631606]
Ous mdr - it was reported that "the stimulation in the ventricles is inhibited when the voltage for the atrial stimulation is set high, even though no electrical activity takes place in the ventricle. The device shows an obviously wrong sensing on the ventricular level at the time of the atrial stimulation. Due to this incorrect sensing, no correct stimulation (ddd pacing) is possible. " no deterioration of the patient's state of health was reported. The product was not returned.
Patient Sequence No: 1, Text Type: D, B5
[25011065]
On 10/20/2014: we were informed this device had been returned for analysis. After the device was returned it was subjected to a visual, mechanical and functional test. Electrical functionality was within specifications during analysis. There was no indication of a materials or manufacturing defect. Attempts to reproduce the complaint were then undertaken. With a standard ddd setting of 60ppm, 200ms av delay, 5v pacing amplitude, 3mv sensitivity and a separate connection of the pacing channels over 500ohm, there was no sensing in the ventricle, as expected. Next, the ventricular sensitivity was increased to its maximum (1mv). Here, as well, there was no ventricular sensing. Then the atrial amplitude was increased to the maximum setting of 17v. Again, no ventricular sensing could be determined. Only after a resistance of below 500ohm was connected between the two pacing channels could the complaint be reproduced. This connection scenario correlates, e. G. , with cardiac wires that are too close to each other in their placement and at the same time reocor has the maximum atrial pacing amplitude setting and a high degree of ventricular sensing. While observing the behavior in the ventricle, there was blanking at the time of the atrial pacing as per specifications. The reocor ventricular channel is non-responsive during the about 20 ms blanking period. This short blanking period permits reocor to sense ventricular sense events with short av delays. If both pacing channels are linked by a low impedance (e. G. , the cardiac wires are placed too close to one another) there is still residual voltage in the input circuitry with this short cross-channel blanking of high atrial stimulus. Due to the high ventricular sensitivity setting, this residual voltage is sensed as a sense after the blanking. The offset by the blanking between the pace (atrium) and sense (ventricle) led is so short that it is hardly detectable for an observer. Therefore, there is an effect as if the atrium and ventricle would be blinking at the same time. In summary, there is no indication of a materials or manufacturing defect. The clinical complaint described could be reproduced only under extreme conditions. The cross-talk observed can be avoided at any time by either placing the atrial and ventricular cardiac wires farther apart or by reducing the atrial pacing amplitude and the ventricular sensitivity.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2014-002743 |
| MDR Report Key | 3984485 |
| Report Source | 01,07 |
| Date Received | 2014-08-06 |
| Date of Report | 2014-07-28 |
| Date of Event | 2014-06-06 |
| Date Mfgr Received | 2014-10-20 |
| Device Manufacturer Date | 2010-11-02 |
| Date Added to Maude | 2014-08-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 6024 JEAN ROAD |
| Manufacturer City | LAKE OSWEGO OR 97035 |
| Manufacturer Country | US |
| Manufacturer Postal | 97035 |
| Manufacturer Phone | 8772459800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REOCOR D |
| Generic Name | EXTERNAL PACEMAKER |
| Product Code | OVJ |
| Date Received | 2014-08-06 |
| Model Number | 365529 |
| Catalog Number | SEE MODEL NO. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Manufacturer Address | WOERMANNKEHRE 1 BERLIN D-12359 GM D-12359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-06 |