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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIQUE; PERMANENT PACING LEAD
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PHYSIQUE; PERMANENT PACING LEAD Back to Search Results
Model Number SCREWVINE 52 SEP
Device Problems Over-Sensing (1438); Low impedance (2285)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2019
Event Type  malfunction  
Manufacturer Narrative
The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.
 
Event Description
Reportedly, during a follow-up performed on (b)(6) 2019 high ventricular lead impedance (3000 ohms) was observed.Additionally, ventricular noise oversensing was observed on the episodes recorded on the device memory and in a real time ecg performed.Ventricular lead polarity switched from bipolar to unipolar on (b)(6) 2019 due to the abnormal impedance values.At the end of the follow-up, the subject pacemaker was programmed on aai mode.Preliminary analysis confirmed the reported abnormal high ventricular lead impedance, as well as the presence of episodes showing non-physiological signals (noise/artifacts) with ventricular noise oversensing since (b)(6) 2019 (at least).Additionally, abnormal low lead impedance and noise oversensing since (b)(6) 2019 (at least) were also observed in the atrial channel.The origin of these non-physiological signals is unknown.It could be located at lead(s) level, connection(s) level or device level: none of them can be confirmed with available data.
 
Event Description
Reportedly, during a follow-up performed on (b)(6) 2019 high ventricular lead impedance (3000 ohms) was observed.Additionally, ventricular noise oversensing was observed on the episodes recorded on the device memory and in a real time ecg performed.Ventricular lead polarity switched from bipolar to unipolar on (b)(6) 2019 due to the abnormal impedance values.At the end of the follow-up, the subject pacemaker was programmed on aai mode.Preliminary analysis confirmed the reported abnormal high ventricular lead impedance, as well as the presence of episodes showing non-physiological signals (noise/artifacts) with ventricular noise oversensing since (b)(6) 2019 (at least).Additionally, abnormal low lead impedance and noise oversensing since (b)(6) 2019 (at least) were also observed in the atrial channel.The origin of these non-physiological signals is unknown.It could be located at lead(s) level, connection(s) level or device level: none of them can be confirmed with available data.
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
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Brand Name
PHYSIQUE
Type of Device
PERMANENT PACING LEAD
MDR Report Key8752767
MDR Text Key149942299
Report Number1000165971-2019-00395
Device Sequence Number1
Product Code OSR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/02/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSCREWVINE 52 SEP
Device Catalogue NumberSCREWVINE 52 SEP
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/13/2019
Date Manufacturer Received08/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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