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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 Migration or Expulsion of Device (1395); Pocket Stimulation (1463); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/10/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).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 device migrated.The patient's right ventricular (rv) lead, right atrial (ra) lead and left ventricular (lv) lead dislodged.The patient reported experiencing diaphragmatic stimulation patient was seen for a revision procedure where the leads were repositioned.During the revision procedure, noise was noted on the lv lead.The lv lead-device header connection was re-established with resolution of the noise.The system remains in service.There were no adverse patient effects reported.
 
Manufacturer Narrative
As of today the product has not yet been received for analysis.Should the product be returned and analysis complete, this report will be updated.
 
Event Description
Subsequent information indicates that the leads dislodged again.The entire system was explanted and replaced.It was reported that the products were to be returned.There were no adverse patient effects.
 
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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
sonali vasekar
4100 hamline ave. n
st. paul, MN 
6515824786
MDR Report Key5372621
MDR Text Key36194068
Report Number2124215-2015-17124
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 11/10/2015
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 Date06/19/2017
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
Initial Date Manufacturer Received 11/10/2015
Initial Date FDA Received01/16/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age58 YR
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