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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 Failure to Capture (1081); Ambient Noise Problem (2877); Capturing Problem (2891); Impedance Problem (2950)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/28/2018
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 this cardiac resynchronization therapy pacemaker (crt-p) system displayed right atrial (ra) loss of capture. The atrial output was set to auto 2. 0 v. The manual threshold test that was run in the office was 2. 4 v. The ra impedance trend is fluctuating between 400 ohms and 1000 ohms. Technical services reviewed device data, and noted the most recent threshold test displayed a good threshold of 0. 7 v. Technical services discussed how the device assesses capture. Technical services had the caller retest in unipolar, and the ra threshold was 0. 6 v and the impedance was 260 ohms. The decision was made to reprogram the ra lead to unipolar and the patient will be monitored. It was noted there was noise on the right ventricular (rv) lead in the past, so that lead is programmed unipolar pace and bipolar sense. At this time, this crt-p and competitor ra and rv leads remain in service and there were no adverse patient effects 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 Key7618290
MDR Text Key111640285
Report Number2124215-2018-08357
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 05/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/22/2018
Device Model NumberU128
Other Device ID NumberVALITUDE X4
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 Received05/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2016
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: 06/20/2018 Patient Sequence Number: 1
Treatment
1291; 1297; 1388T; 253-05; 283-03; 293-09; 294-05; 430-07; 433-02; 467-01; 4674; MISMATCH; PR48B; S606; U128
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