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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); Impedance Problem (2950)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2017
Event Type  Injury  
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.
 
Event Description
Boston scientific received information that a lead safety switch (lss) was declared for both the right ventricular (rv) lead and left ventricular (lv) lead. The pacing impedance for both leads was greater than 2000 ohms. The impedances then went back to a normal range. It was noted there was a lot of noise present after the lss triggered. The noise could be reproduced with isometrics. The noise was oversensed, which resulted in asystole of greater than two seconds. The physician planned to program the device back to a bipolar configuration because the patient is pacer dependent. No further actions were taken. The root cause for the clinical observations was not determined. Additional information was received that further review of the patient¿s data found noise episodes from four months earlier. The noise presented on the right atrial (ra) and rv channels and was oversensed. Boston scientific technical services (ts) reviewed the electrograms (egms) and stated the noise was from the cardiac resynchronization therapy pacemaker (crt-p) oversensing the minute ventilation signal. Ts discussed how to program the rate response trend and minute ventilation features off. It was also noted that another manufacturer¿s ra lead impedance measurement was out of range two years earlier. However, currently the ra lead impedance measurements were within range. The patient was scheduled to have the minute ventilation feature programmed off. The crt-p and all leads remain in service and no adverse patient effects were reported.
 
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Brand NameACCOLADE
Type of DeviceIMPLANTABLE 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 Key7353644
MDR Text Key102936378
Report Number2124215-2018-03931
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
PMA/PMN Number
P030005/S113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 01/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/18/2017
Device Model NumberU128
Other Device ID NumberVALITUDE X4
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received01/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/18/2015
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: 03/20/2018 Patient Sequence Number: 1
Treatment
5076; MISMATCH; U128
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