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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUIDANT PUERTO RICO BV ACCOLADE IMPLANTABLE PULSE GENERATOR

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GUIDANT PUERTO RICO BV ACCOLADE IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number ACCESSORY
Device Problem Human-Device Interface Problem (2949)
Patient Problem Cardiac Tamponade (2226)
Event Date 02/18/2016
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 this patient with an cardiac resynchronization therapy pacemaker (crt-p) device had perforation and tamponade during implant. Moreover, the patient had history of atrial fibrillation (af). The device remains in service. No additional adverse patient effects were reported.
 
Event Description
Boston scientific received information that during implant procedure for this cardiac resynchronization therapy pacemaker (crt-p) device, when canulating the coronary sinus to implant another manufacturer's left ventricular (lv) lead, a perforation and tamponade occurred. Additional information was received that there was a pericardial effusion and the pericardium was successfully drained during the procedure. At this time there is no evidence to support that the crt-p contributed to the perforation and both the crt-p and another manufacturer's lv lead remain in service. No additional adverse patient effects were reported.
 
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Brand NameACCOLADE
Type of DeviceIMPLANTABLE PULSE GENERATOR
Manufacturer (Section D)
GUIDANT PUERTO RICO BV
guidant ireland
clonmel, tipperary ireland
Manufacturer (Section G)
GUIDANT PUERTO RICO BV
guidant ireland
clonmel, tipperary ireland
Manufacturer Contact
sonali vasekar
4100 hamline ave. n
st. paul, MN 
6515824786
MDR Report Key5632506
MDR Text Key44447158
Report Number2124215-2016-06599
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/06/2018
Device Model NumberACCESSORY
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 Received05/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/06/2016
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: 05/04/2016 Patient Sequence Number: 1
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