Model Number GALI 4LV SONR CRT-D 2844 |
Device Problems
High impedance (1291); Misconnection (1399); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2022 |
Event Type
malfunction
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Event Description
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Reportedly, the ventricular lead impedance was above 3000 ohms during defibrillator implantation.Tests were performed with psa and the lead measurements were within normal values.The device was therefore replaced with another one.
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Manufacturer Narrative
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The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.
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Manufacturer Narrative
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Evaluation: - the electrical characteristics of the returned device conformed to established specifications.Upon reception of the device, pacing pulses were generated appropriately by the device.- the analysis confirms that the connection system of the subject pacemaker functioned as specified using a duplicate torque-limiting screwdriver.- no tightening mark was observed on the right and left ventricular set screw tips which could indicate an inappropriate connection at the ventricular level.- it should be noted that upon insertion of the lead connector pin, it is important to verify the lead connector pin protrudes beyond the connector port prior to and during any screwing operation as to assure an appropriate crt-d-lead connection.-no issue is suspected on the subject crt-d.
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Event Description
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Reportedly, the ventricular lead impedance was above 3000 ohms during defibrillator implantation.Tests were performed with psa and the lead measurements were within normal values.The device was therefore replaced with another one.
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Event Description
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Reportedly, during the implantation, a high rv coil continuity (> 3000 ohms) was observed during the connection on the rv df1 connector.Regarding the svc connector, the impedance was within normal range.Therefore defibrillator was removed and no abnormality was observed with the new device.
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Manufacturer Narrative
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Additional information: on 22 december 2022, additional information was received regarding the description of the event, which allowed the investigation to be adjusted.Evaluation: please refer to the attached analysis report.
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Search Alerts/Recalls
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