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

Model Number PLATINIUM VR 1210

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

Patient Problem No Information (3190)

Event Date 04/09/2019

Event Type  Injury  

Event Description

The defibrillation system was implanted on (b)(6) 2017.Reportedly, during the follow-up performed on (b)(6) 2019, more than 1100 fvt/vt episodes have been recorded in the device memory and 11 of these episodes were treated.One episode showed a noise pattern typical of a lead issue.A decrease in ventricular lead impedance measurements was observed and the recommended replacement time (rrt) displayed was less than 3 months.Re-intervention was performed on (b)(6) 2019; the icd was explanted and should be returned for analysis.The associated lead was abandoned in the patient's body because extraction was impossible.Based on preliminary analysis, a ventricular lead issue is the most probable hypothesis.

Manufacturer Narrative

Based on the preliminary analysis of the returned device, a hardware failure at the level of an integrated circuit is suspected.Analysis confirmed that the connection system conformed to established specifications.

Event Description

The defibrillation system was implanted on (b)(6) 2017.Reportedly, during the follow-up performed on (b)(6) 2019, more than 1100 fvt/vt episodes have been recorded in the device memory and 11 of these episodes were treated.One episode showed a noise pattern typical of a lead issue.A decrease in ventricular lead impedance measurements was observed and the recommended replacement time (rrt) displayed was less than 3 months.Re-intervention was performed on 29 april 2019; the icd was explanted and should be returned for analysis.The associated lead was abandoned in the patient's body because extraction was impossible.Based on preliminary analysis, a ventricular lead issue is the most probable hypothesis.

Manufacturer Narrative

D3 (email address) corrected.F14 (email address) corrected.G1-2 (first name, last name, email address, phone number) corrected.Please refer to the attached analysis report.- attachment: [20191018 - file-2019-01369 - analysis_and_closure_report_resp-2019-00589.Pdf].

Event Description

The defibrillation system was implanted on 9 october 2017.Reportedly, during the follow-up performed on (b)(6) 2019, more than 1100 fvt/vt episodes have been recorded in the device memory and 11 of these episodes were treated.One episode showed a noise pattern typical of a lead issue.A decrease in ventricular lead impedance measurements was observed and the recommended replacement time (rrt) displayed was less than 3 months.Re-intervention was performed on 29 april 2019; the icd was explanted and should be returned for analysis.The associated lead was abandoned in the patient's body because extraction was impossible.Based on preliminary analysis, a ventricular lead issue is the most probable hypothesis.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• MDR Report Key: 8577180
• MDR Text Key: 143934869
• Report Number: 1000165971-2019-00267
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527014357
• UDI-Public: (01)08031527014357(11)170331(17)181031
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2019

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: 10/31/2018
• Device Model Number: PLATINIUM VR 1210
• Device Catalogue Number: PLATINIUM VR 1210
• Device Lot Number: S0259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/12/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 05/03/2019
• Supplement Dates Manufacturer Received: 07/19/2019; 10/18/2019
• Supplement Dates FDA Received: 08/14/2019; 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention