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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCIVA ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION PERCIVA ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number D413
Device Problems Signal Artifact/Noise (1036); High impedance (1291); Loose or Intermittent Connection (1371); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Electric Shock (2554)
Event Date 03/17/2023
Event Type  Injury  
Manufacturer Narrative
No additional information is available.If additional information becomes available the report will be updated at that time.
 
Event Description
It was reported that the patient received multiple inappropriate shocks post implant due to oversensing of noise.The right ventricular (rv) lead pacing impedance measurement was greater than 3000 ohms and the shocking impedance measurement was 70 ohms.A revision procedure was performed where it was noted that the rv lead was not properly inserted into the header of the implantable cardioverter defibrillator (icd).The lead was tested on the pacing system analyzer (psa) and yielded a good pacing impedance measurement of 700 ohms.During the revision, the insulation of the lead became damaged.Subsequently the rv lead was explanted and successfully replaced.The icd remains in service with the new rv lead.No additional adverse patient effects were reported.The explanted rv lead is not expected to be returned for analysis as it was contaminated during the procedure.
 
Manufacturer Narrative
No additional information is available.If additional information becomes available the report will be updated at that time.This report is being filed to correct h6 impact code and add a code that was inadvertently left off last report.
 
Event Description
It was reported that the patient received multiple inappropriate shocks post implant due to oversensing of noise.The right ventricular (rv) lead pacing impedance measurement was greater than 3000 ohms and the shocking impedance measurement was 70 ohms.A revision procedure was performed where it was noted that the rv lead was not properly inserted into the header of the implantable cardioverter defibrillator (icd).The lead was tested on the pacing system analyzer (psa) and yielded a good pacing impedance measurement of 700 ohms.During the revision, the insulation of the lead became damaged.Subsequently the rv lead was explanted and successfully replaced.The icd remains in service with the new rv lead.No additional adverse patient effects were reported.The explanted rv lead is not expected to be returned for analysis as it was contaminated during the procedure.
 
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Brand Name
PERCIVA ICD DR
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key16619284
MDR Text Key312043126
Report Number2124215-2023-14237
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P960040/S385
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 03/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberD413
Device Catalogue NumberD413
Device Lot Number131612
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/13/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/20/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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