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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD
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DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD Back to Search Results
Model Number 7171Q/65
Medical Device Problem Codes Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Discomfort (2330)
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a patient presented for a follow up.The patient's right ventricular (rv) lead exhibited oversensing noise.The patient received inappropriate therapy and had very violent episodes of vomiting.The rv lead was suspected to be dislodged.The device was reprogrammed.There were no patient consequences.
 
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Brand Name
DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR
Common Device Name
DEFIBRILLATION LEAD
MDR Report Key12740264
Report Number2017865-2021-35395
Device Sequence Number14592699
Product Code NVY
UDI-Device Identifier05414734503297
UDI-Public05414734503297
Combination Product (Y/N)Y
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P950022
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/02/2021
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
Operator of Device Health Professional
Device Expiration Date10/31/2010
Device Model Number7171Q/65
Device Catalogue Number7171Q-65
Device Lot Number2871929
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/13/2021
Initial Report FDA Received Date11/02/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured10/26/2009
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age67 YR
Patient Weight82
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