MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L - CRM ORCHESTRA PLUS LINK; UNKNOWN

Model Number ORCHESTRA PLUS LINK

Device Problem Wireless Communication Problem (3283)

Patient Problems Bacterial Infection (1735); No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2017

Event Type  malfunction  

Event Description

Reportedly, the wireless communication did not work during implantation with two different rf heads.The icd could be interrogated using inductive telemetry.It was also observed that the svc coil continuity is abnormal, but this results from a programming error (the defibrillation lead is a simple coil lead but was indicated as a double coils lead in patient data).Reportedly, the patient has an infection and was kept isolated until he can leave the hospital.

Manufacturer Narrative

Please refer to the analysis report.(b)(4).

Event Description

Reportedly, the wireless communication did not work during implantation with two different rf heads.The icd could be interrogated using inductive telemetry.It was also observed that the svc coil continuity is abnormal, but this results from a programming error (the defibrillation lead is a simple coil lead but was indicated as a double coils lead in patient data).Reportedly, the patient has an infection and was kept isolated until he can leave the hospital.

• Brand Name: ORCHESTRA PLUS LINK
• Type of Device: UNKNOWN
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L - CRM; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer (Section G): MANUFACTURED IN FRANCE FOR SORIN GROUP ITALIE, SRL; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 7145493
• MDR Text Key: 95904340
• Report Number: 1000165971-2017-00957
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORCHESTRA PLUS LINK
• Device Catalogue Number: ORCHESTRA PLUS LINK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/04/2017
• Event Location: Hospital
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1