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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 Failure to Capture (1081); Fracture (1260); High impedance (1291)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/22/2015
Event Type  Injury  
Event Description
Boston scientific received information that this right ventricular (rv) lead exhibited high out of range pacing impedance measurements and loss of capture.As a fracture was suspected, the lead was explanted and replaced.No adverse patient effects were reported.
 
Manufacturer Narrative
(b)(4).The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.
 
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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 55112
6515824786
MDR Report Key4903627
MDR Text Key16961145
Report Number2124215-2015-08843
Device Sequence Number1
Product Code DTD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/24/2016
Device Model Number7742
Other Device ID NumberINGEVITY MRI
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Manufacturer Received06/23/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/24/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
7742; J172
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
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