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

Model Number PLATINIUM DR 1540

Device Problems Device Sensing Problem (2917); Wireless Communication Problem (3283)

Patient Problem No Information (3190)

Event Date 08/15/2019

Event Type  Injury  

Event Description

Reportedly, a sensing error occurred when recording r-waves amplitude : pacing system analyzer measured r-waves amplitude above 14.0 mv while the programmer measured r-waves from 1.08 to 6.0 mv.The subject device was replaced and r-waves amplitude were then recorded at above 17.0 mv.Additionally, issue with the wireless communication was reported, deemed related to the emi field created by the x-ray machine used in the laboratory.

Manufacturer Narrative

Preliminary analysis of the returned device and analysis of expertise files did not reveal any issue with the icd.

Event Description

Reportedly, a sensing error occurred when recording r-waves amplitude : pacing system analyzer measured r-waves amplitude above 14.0 mv while the programmer measured r-waves from 1.08 to 6.0 mv.The subject device was replaced and r-waves amplitude were then recorded at above 17.0 mv.Additionally, issue with the wireless communication was reported, deemed related to the emi field created by the x-ray machine used in the laboratory.

Manufacturer Narrative

Please refer to the attached analysis report.- attachment: [20191119 - file-2019-02965 - analysis_and_closure_report_resp-2019-01619.Pdf].

Event Description

Reportedly, a sensing error occurred when recording r-waves amplitude : pacing system analyzer measured r-waves amplitude above 14.0 mv while the programmer measured r-waves from 1.08 to 6.0 mv.The subject device was replaced and r-waves amplitude were then recorded at above 17.0 mv.Additionally, issue with the wireless communication was reported, deemed related to the emi field created by the x-ray machine used in the laboratory.

• 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: 8974809
• MDR Text Key: 156918786
• Report Number: 1000165971-2019-00531
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527016870
• UDI-Public: (01)08031527016870(11)180118(17)190818
• 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: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2019
• Device Model Number: PLATINIUM DR 1540
• Device Catalogue Number: PLATINIUM DR 1540
• Device Lot Number: S0300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/15/2019
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention