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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE¿ EL ICD DR
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BOSTON SCIENTIFIC CORPORATION RESONATE¿ EL ICD DR Back to Search Results
Model Number D433
Device Problems High impedance (1291); Off-Label Use (1494); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/15/2019
Event Type  malfunction  
Event Description
It was reported that during the implant of this implantable cardioverter defibrillator (icd), shock impedance measurements of greater than 200 ohms were noted.A code 1005 was also observed, indicating an open circuit condition was detected during shock delivery.It was noted that the physician attempted to use a covering over the device due to a suspected metal allergy for the patient.A different lead was implanted with this same device with no further reported issues.No adverse patient effects were reported.
 
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Brand Name
RESONATE¿ EL ICD DR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key9212464
MDR Text Key164892601
Report Number2124215-2019-20267
Device Sequence Number1
Product Code LWS
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 10/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberD433
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/15/2019
Initial Date FDA Received10/20/2019
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
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