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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC; IMPLANTABLE LEAD
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BOSTON SCIENTIFIC; IMPLANTABLE LEAD Back to Search Results
Device Problems Pocket Stimulation (1463); Human-Device Interface Problem (2949)
Patient Problems Muscle Stimulation (1412); Cardiac Perforation (2513)
Event Date 08/31/2018
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 right ventricular (rv) lead experienced diaphragmatic stimulation.Boston scientific technical services (ts) noted that perforation was found.In addition, lead revision was scheduled.This rv lead remains in service.No additional adverse patient effects were reported.
 
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Type of Device
IMPLANTABLE LEAD
Manufacturer (Section D)
BOSTON SCIENTIFIC
Manufacturer Contact
timothy degroot
4100 hamline ave. n
st. paul, MN 55112
6515826168
MDR Report Key8038538
MDR Text Key126140041
Report Number2124215-2018-19339
Device Sequence Number1
Product Code NVY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 08/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received08/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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