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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT CRM S.R.L. GALI; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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MICROPORT CRM S.R.L. GALI; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number GALI 4LV SONR CRT-D 2844
Device Problems High impedance (1291); Misconnection (1399); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2022
Event Type  malfunction  
Event Description
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.
 
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 microport crm that was cleared or approved by fda for marketing in the united states.
 
Manufacturer Narrative
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.
 
Event Description
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.
 
Event Description
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.
 
Manufacturer Narrative
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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Brand Name
GALI
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Manufacturer (Section D)
MICROPORT CRM S.R.L.
via crescentino s.n
saluggia (vc) 13040
IT  13040
Manufacturer (Section G)
MICROPORT CRM S.R.L.
via crescentino s.n
saluggia (vc) 13040
IT   13040
Manufacturer Contact
elodie vincent
via crescentino s.n
saluggia (vc) 13040
IT   13040
MDR Report Key15786808
MDR Text Key303580515
Report Number1000165971-2022-00509
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup,Followup
Report Date 01/20/2023
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 NumberGALI 4LV SONR CRT-D 2844
Device Catalogue NumberGALI 4LV SONR CRT-D 2844
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/17/2022
Initial Date FDA Received11/14/2022
Supplement Dates Manufacturer Received12/05/2022
12/22/2022
Supplement Dates FDA Received12/12/2022
01/20/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient EthnicityNon Hispanic
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