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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND COGNIS IMPLANTABLE CHF PULSE GENERATOR

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GUIDANT CRM CLONMEL IRELAND COGNIS IMPLANTABLE CHF PULSE GENERATOR Back to Search Results
Model Number P107
Device Problems Device Alarm System (1012); Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2017
Event Type  Injury  
Manufacturer Narrative
This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory. Review of the device memory indicated that a low voltage alert, code 1003, was recorded. The battery voltage was lower than expected, but still supported full device function. Using historical daily battery voltage measurement data, engineers determined that this device was demonstrating behavior consistent with a high current condition associated with a compromised low voltage capacitor connected to the device's battery. Low voltage capacitors are used in the device's high voltage charging operation in order to facilitate fast charge times. Malfunction of these capacitors resulted in a high current drain, which was depleting this device's battery faster than normal.
 
Event Description
Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) emitted tones and recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity. Data analysis showed the battery appeared to be depleting more quickly than expected. Device replacement was recommended. This crt-d was explanted. No additional adverse patient effects were reported.
 
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Brand NameCOGNIS
Type of DeviceIMPLANTABLE CHF PULSE GENERATOR
Manufacturer (Section D)
GUIDANT CRM CLONMEL IRELAND
guidant ireland
clonmel, tipperary ireland
Manufacturer (Section G)
GUIDANT CRM CLONMEL IRELAND
guidant ireland
clonmel, tipperary ireland
Manufacturer Contact
tim degroot
4100 hamline ave. n
st. paul, MN 
6515826168
MDR Report Key7195865
MDR Text Key97396626
Report Number2124215-2018-00910
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 11/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/18/2013
Device Model NumberP107
Other Device ID NumberCOGNIS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received11/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/16/2018 Patient Sequence Number: 1
Treatment
0186; 4096; 4555; P107
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