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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXTERNAL MANUFACTURER POSSIS; IMPLANTABLE LEAD
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EXTERNAL MANUFACTURER POSSIS; IMPLANTABLE LEAD Back to Search Results
Model Number 4320
Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/24/2015
Event Type  Injury  
Event Description
Boston scientific received information that the patient received 28 inappropriate shocks due to noise and oversensing of the right ventricular (rv) lead and resulted in device therapy exhaustion.Boston scientific technical services (ts) was contacted and advised that the integrity of the lead system is in question.The leads were capped and replaced.No adverse patient effects were reported.
 
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.
 
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Brand Name
POSSIS
Type of Device
IMPLANTABLE LEAD
Manufacturer (Section D)
EXTERNAL MANUFACTURER
Manufacturer (Section G)
EXTERNAL MANUFACTURER
Manufacturer Contact
sonali vasekar
4100 hamline ave. n
st. paul, MN 55112
6515824786
MDR Report Key4883139
MDR Text Key16560580
Report Number2124215-2015-06455
Device Sequence Number1
Product Code NHW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/01/1994
Device Model Number4320
Other Device ID Number---
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received04/29/2015
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
Treatment
0041; 0040; 4320; 1746; 1635; 1600
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age70 YR
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