MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY ISOLINE; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number ISOLINE 2CT6

Device Problems Over-Sensing (1438); Low impedance (2285)

Patient Problem Diminished Pulse Pressure (2606)

Event Date 05/29/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, during a icd interrogation in the emergency room, where the patient went for a pressure drop, the physician identified some noises on the rv channel and the alert about svc impedance below 200 ohm.No inappropriate shock was delivered.On (b)(6) 2020 the subject lead was abandoned and replaced by a df4 lead.The associated icd was also replaced accordingly.Preliminary review of the available patient files was suspicious of a lead issue at the ventricular level.

Event Description

On (b)(6) 2020, during a icd interrogation in the emergency room, where the patient went for a pressure drop, the physician identified some noises on the rv channel and the alert about svc impedance below 200 ohm.No inappropriate shock was delivered.On (b)(6) 2020 the subject lead was abandoned and replaced by a df4 lead.The associated icd was also replaced accordingly.Preliminary review of the available patient files was suspicious of a lead issue at the ventricular level.

Manufacturer Narrative

(b)(4).

• Brand Name: ISOLINE
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; via crescentino s.n.; .; saluggia 13040 ; IT 13040
• MDR Report Key: 10161381
• MDR Text Key: 195370331
• Report Number: 1000165971-2020-00431
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2012
• Device Model Number: ISOLINE 2CT6
• Device Catalogue Number: ISOLINE 2CT6
• Device Lot Number: 2386
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/29/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 08/26/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0928-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention