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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U225
Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/31/2021
Event Type  malfunction  
Manufacturer Narrative
No additional information is available. If additional information becomes available the report will be updated at that time.
 
Event Description
It was reported that during an upgrade procedure from a pacemaker to a cardiac resynchronization therapy pacemaker (crt-p), the physician chose to leave another manufacturer's pacemaker and epicardial right atrial (ra) and right ventricular (rv) leads connected and active while connecting the new left ventricular (lv) lead to the new device since the patient was rv pacer dependent. The crt-p paced in the lv, but every two beats, it detected something in the rv channel, even though there was no lead inserted into the header yet. The crt-p was not pacing in the lv at 70 bpm like it was programmed, the physician completely disconnected the existing pacemaker, but the pacing rate remained the same and the lv channel continued to detect a signal from the rv channel. This caused lv pacing at a lower rate than desired and rv pacing inhibition. Boston scientific technical services (ts) was consulted and discussed the behavior observed with an event detected on rv channel at a rate of 30 bpm is expected device behavior related to the auto lead detect feature. To detect if a lead is attached to the device, the device sends a signal to measure impedance on the rv lead port every two seconds. This test starts when the device battery is attached and runs until a normal impedance is measured for the rv lead. The signal is delivered with the same amplitude and duration as the daily impedance measurement pulses, however due to the high impedance when no lead is attached to the device, the signal was detected on rv sensing channel. Since this device was taken out of storage mode manually, the auto lead detect signal continues to be seen on the rv electrogram (egm) every two seconds until a normal impedance is detected. Ts noted that for patients that do not have an intrinsic rhythm, it is recommend to assure pacing using the pacing system analyzer (psa) during a change out procedure to avoid pacing inhibition related to the auto lead detect signal or related to noise when unplugging rv lead. The crt-p and leads remain in service and no adverse patient effects were reported.
 
Manufacturer Narrative
No additional information is available. If additional information becomes available the report will be updated at that time.
 
Event Description
It was reported that during an upgrade procedure from a pacemaker to a cardiac resynchronization therapy pacemaker (crt-p), the physician chose to leave another manufacturer's pacemaker and epicardial right atrial (ra) and right ventricular (rv) leads connected and active while connecting the new left ventricular (lv) lead to the new device since the patient was rv pacer dependent. The crt-p paced in the lv, but every two beats, it detected something in the rv channel, even though there was no lead inserted into the header yet. The crt-p was not pacing in the lv at 70 bpm like it was programmed, the physician completely disconnected the existing pacemaker, but the pacing rate remained the same and the lv channel continued to detect a signal from the rv channel. This caused lv pacing at a lower rate than desired and rv pacing inhibition. Boston scientific technical services (ts) was consulted and discussed the behavior observed with an event detected on rv channel at a rate of 30 bpm is expected device behavior related to the auto lead detect feature. To detect if a lead is attached to the device, the device sends a signal to measure impedance on the rv lead port every two seconds. This test starts when the device battery is attached and runs until a normal impedance is measured for the rv lead. The signal is delivered with the same amplitude and duration as the daily impedance measurement pulses, however due to the high impedance when no lead is attached to the device, the signal was detected on rv sensing channel. Since this device was taken out of storage mode manually, the auto lead detect signal continues to be seen on the rv electrogram (egm) every two seconds until a normal impedance is detected. Ts noted that for patients that do not have an intrinsic rhythm, it is recommend to assure pacing using the pacing system analyzer (psa) during a change out procedure to avoid pacing inhibition related to the auto lead detect signal or related to noise when unplugging rv lead. The crt-p and leads remain in service and no adverse patient effects were reported.
 
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Brand NameVISIONIST CRT-P
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key13445456
MDR Text Key285219008
Report Number2124215-2022-02798
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU225
Device Catalogue NumberU225
Device Lot Number719428
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

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