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

Model Number PARADYM RF DR 9550

Device Problem Wireless Communication Problem (3283)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the subject device could not be interrogated by the remote monitoring system.Issue is suspected on the rf communication level.There was no successful patient initiated transmission.An investigation is required.

Manufacturer Narrative

(b)(4).Preliminary analysis revealed that the root cause of the reported behaviour was identified.One specific parameter was not properly updated on the us1 back office environment.This prevented rf communication between smartview monitors and the icds and crt-ds of the us patients who are implanted with paradym rf and intensia devices that embed zl102 rf chip.

Event Description

It was reported that the subject device could not be interrogated by the remote monitoring system.Issue is suspected on the rf communication level.There was no successful patient initiated transmission.An investigation is required.

Manufacturer Narrative

Udi: (b)(4).

Event Description

It was reported that the subject device could not be interrogated by the remote monitoring system.Issue is suspected on the rf communication level.There was no successful patient initiated transmission.An investigation is required.

• Brand Name: PARADYM RF
• 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
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; 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: 5794196
• MDR Text Key: 50294411
• Report Number: 1000165971-2016-00405
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP060027
• 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,Followup
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2016
• Device Model Number: PARADYM RF DR 9550
• Device Catalogue Number: PARADYM RF DR 9550
• Device Lot Number: 2903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/21/2016
• Event Location: Other
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1