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

Model Number ISOLINE 2CR6

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 08/07/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, the patient visited the hospital due to inappropriate shock delivery.Icd check was conducted and noise was confirmed to have frequently occurred since (b)(6) 2019, resulting in inappropriate shock delivery.The observed noises were typical of lead fracture.Low icd lead impedance was recorded twice on the icd lead impedance trend.Reproductive test was performed, but noise was not reproduced.The physician deactivate shock therapies and the patient was hospitalized.

Manufacturer Narrative

Preliminary investigation results suggest an issue with the subject lead.

Event Description

On (b)(6) 2019, the patient visited the hospital due to inappropriate shock delivery.Icd check was conducted and noise was confirmed to have frequently occurred since (b)(6) 2019, resulting in inappropriate shock delivery.The observed noises were typical of lead fracture.Low icd lead impedance was recorded twice on the icd lead impedance trend.Reproductive test was performed, but noise was not reproduced.The physician deactivate shock therapies and the patient was hospitalized.

Event Description

On (b)(6) 2019, the patient visited the hospital due to inappropriate shock delivery.Icd check was conducted and noise was confirmed to have frequently occurred since (b)(6) 2019, resulting in inappropriate shock delivery.The observed noises were typical of lead fracture.Low icd lead impedance was recorded twice on the icd lead impedance trend.Reproductive test was performed, but noise was not reproduced.The physician deactivate shock therapies and the patient was hospitalized.

• 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: 8953438
• MDR Text Key: 156906484
• Report Number: 1000165971-2019-00509
• 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,Followup
• Report Date: 11/22/2019

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: 04/22/2012
• Device Model Number: ISOLINE 2CR6
• Device Catalogue Number: ISOLINE 2CR6
• Device Lot Number: 2431
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/08/2019
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 09/02/2019
• Supplement Dates Manufacturer Received: 09/20/2019; 10/29/2019
• Supplement Dates FDA Received: 10/15/2019; 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0928-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention