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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); Ambient Noise Problem (2877)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2018
Event Type  malfunction  
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 on this cardiac resynchronization therapy pacemaker (crt-p) system due to high out of range pacing impedance measurements on the left ventricular (lv) lead, measuring greater than 2000 ohms. It was noted that the right ventricular (rv) lead exhibited noise and the impedance measurements increased from about 500 ohms to 1400 ohms. The patient's rv lead was a non-boston scientific product. Boston scientific technical services (ts) provided troubleshooting options. The physician elected to continue to monitor the patient and crt-p system. This crt-p system remains in service. No adverse patient effects were reported.
 
Event Description
Additional information was received which indicated that this crt-p system exhibited noise on the left ventricular (lv) lead. It was noted the noise was not sensed and all other measurements were within normal limits. Boston scientific technical services (ts) recommended continuing to monitor. This crt-p remains in service. 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 Key7761012
MDR Text Key116371264
Report Number2124215-2018-14960
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/07/2019
Device Model NumberU128
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received08/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2017
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: 08/08/2018 Patient Sequence Number: 1
Treatment
4671; 4675; 5076; 7741; ADDRL1; U128
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