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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND ACCOLADE; IMPLANTABLE PULSE GENERATOR

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GUIDANT CRM CLONMEL IRELAND ACCOLADE; IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number U128
Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2017
Event Type  Injury  
Manufacturer Narrative
The field representative was contacted to confirm if any further action would be taking place.At this time there is no further information available.If additional information becomes available, this report will be updated.
 
Event Description
Boston scientific received information that a health care professional (hcp) reported observing noise with this patient's cardiac resynchronization therapy defibrillator (crt-d) and competitor leads.Boston scientific technical services (ts) reviewed remote monitoring data and noted the right atrial (ra) lead impedances increased from 400 to 2532, then decreased again; with three lead safety switch activations.The right ventricular (rv) lead impedances were trending in the low 400 ohm range, with a single spike to 769 ohms.Several episodes showed myopotential noise on the ra, but the ra was programmed bipolar pace, unipolar sense.An additional episode from (b)(6) 2017 showed minute ventilation (mv) oversensing on the rv channel with a 9 second duration.The patient does not have an underlying rhythm.The respiratory rate trend (rrt) was programmed off.No adverse patient effects were reported.
 
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Brand Name
ACCOLADE
Type of Device
IMPLANTABLE 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 Key7195009
MDR Text Key97366378
Report Number2124215-2017-22843
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559402
UDI-Public00802526559402
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/16/2017
Device Model NumberU128
Other Device ID NumberVALITUDE X4
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 11/21/2017
Initial Date FDA Received01/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
5076; ADDRL1; MISMATCH; U128
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age84 YR
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