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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CPI - DEL CARIBE INGEVITY; IMPLANTABLE LEAD

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CPI - DEL CARIBE INGEVITY; IMPLANTABLE LEAD Back to Search Results
Model Number 7742
Device Problems High impedance (1291); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/21/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4); the product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.
 
Event Description
Boston scientific received information that this right atrial (ra) lead exhibited high out-of-range impedances.A lead dislodgement was confirmed.Attempts to reposition were unsuccessful due to helix issues.No adverse patient effects were reported.The lead was explanted.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, visual inspection noted the helix was extended and dried blood was present in the helix housing.Resistance testing found the lead was not electrically continuous.Detailed analysis confirmed that the cathode conductor coil was fractured at the distal end of the terminal pin.Microscopic analysis confirmed that the lead became fractured due to torsional overstress.Based upon the clinical observations and the laboratory findings, we believe the conductor coil became fractured during attempts to extend/retract the helix.
 
Event Description
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Brand Name
INGEVITY
Type of Device
IMPLANTABLE LEAD
Manufacturer (Section D)
CPI - DEL CARIBE
guidant puerto rico b. v.
dorado PR
Manufacturer (Section G)
CPI - DEL CARIBE
guidant puerto rico b. v.
dorado PR
Manufacturer Contact
sonali vasekar
4100 hamline ave. n
st. paul, MN 
6515824786
MDR Report Key5211694
MDR Text Key30801029
Report Number2124215-2015-13619
Device Sequence Number1
Product Code NVZ
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/09/2015
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 Date04/21/2017
Device Model Number7742
Other Device ID NumberINGEVITY MRI
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 09/22/2015
Initial Date FDA Received11/09/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2015
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;
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