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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)

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BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) Back to Search Results
Model Number U125
Device Problems High impedance (1291); Over-Sensing (1438); Failure to Read Input Signal (1581); Low impedance (2285); High Capture Threshold (3266)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2021
Event Type  malfunction  
Event Description
It was reported that this (b)(6) patient was playing with an ipad and abruptly had chest pain once the patient got it too close to the chest, inquiries about possible device related issues were made. Technical services (ts) reviewed the case and noticed proper atrial and ventricular sensing of 100 bpm during the moment in question. Ts discussed the possibility of the patient feeling asynchronous pacing at 100 bpm if there are magnets in the ipad case and/or pacing inhibition due to electromagnetic interference (emi). However, patient's heart rate at the moment of the ipad interaction discards pacing inhibition, and ts wonder instead if the patient could have felt the asynchronous pacing. Because the patient suffers from intermittent heart block, the physician believes the patient may have had some heart block on the moment in question. Ts recommended keeping emi sources with appropriate distance from the crt-p. After further reviewing this patient's past data, an increase in the right ventricular (rv) threshold and a decrease in the rv pacing impedance were noticed, along with a couple of signal artifact monitor (sam) events caused by minute ventilation noise oversensing on both rv and right atrial (ra) channels. High pacing impedance out-of-range (oor) was noticed during the second sam event. In addition, intermittent left ventricular (lv) and rv pacing impedance spikes high out-of-range (oor) were noticed from previous dates, as well as low amplitude r-waves on the rv lead. Attempts to obtain additional information were unsuccessful. This patient's implantable system remains in service and no adverse patient effects were reported.
 
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Brand NameVALITUDE CRT-P
Type of DeviceCARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (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 Key13923201
MDR Text Key288056129
Report Number2124215-2022-05194
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559389
UDI-Public00802526559389
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/13/2021
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number714120
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/03/2019
Is the Device Single Use? Yes
Type of Device Usage Initial

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