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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION INVIVE CRT-P IMPLANTABLE PULSE GENERATOR, PACEMAKER (WITH CRT) Back to Search Results
Model Number V173
Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591); Impedance Problem (2950)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/14/2013
Event Type  malfunction  
Manufacturer Narrative
Based on data analysis of (191) model v173 devices, (8) red alert (remote monitoring disabled due to limited battery capacity), (73) red alert (right ventricular pacing lead impedance out of range), (6) red alert (device in safety mode), (165) yellow alert (left ventricular pacing lead impedance out of range), and (401) yellow alert (atrial pacing lead impedance out of range) were identified. The alert dates occurred from february 14, 2013 through june 21, 2019. This investigation will be updated should further information be provided.
 
Event Description
It was reported that boston scientific imagineif team conducted a retrospective data analysis (latitude imagineif data study (phase 2)). Based on data analysis, follow-up patient populations were stratified into two groups with a goal to determine which patients could be followed remotely (computer-based health care) versus those patients that may require in-clinic follow-up. Data from 20,000 (5000 icds, 5000 pacemakers, 5000 crt-p and 5000 crt-d) devices implanted in the united states was collected using latitude nxt and de-identified for analysis. All data was used in accordance with patient confidentiality laws, regulations, and data use agreements. A listing of possible malfunctions or product deficiencies that would satisfy the definition of a complaint were sent to the complaint management center (cmc) for further processing. Red alerts from the patient latitude monitoring are device conditions that could potentially leave the patient without available device therapy. Each individual red alert needs to be assessed by the clinician or physician. Yellow alerts are declared when a certain device condition or patient heart-health issue is detected that may warrant clinician review or investigation.
 
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Brand NameINVIVE CRT-P
Type of DeviceIMPLANTABLE PULSE GENERATOR, PACEMAKER (WITH CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
GUIDANT CRM CLONMEL IRELAND
guidant ireland
cashel rd.
clonmel, tipperary ireland
EI
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key9275410
MDR Text Key169302194
Report Number2124215-2019-23720
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S079
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 11/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberV173
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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