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 Pacing Problem (1439)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2021

Event Type  malfunction  

Event Description

Reportedly, during a follow-up performed on (b)(6) 2021, it was that a non-sustained episode recorded on (b)(6) 2020 at 09:26 showed noise oversensing related to electromagnetic interferences (emi) on both channels.After a period of fifteen (15) short cycles, the noise algorithm was activated and a pause of pacing of around four seconds occurred.Preliminary analysis results confirmed the reported noise oversensing on both channels in the episode recorded on (b)(6) 2020, most probably due to emi at 50hz.The observed pause of pacing was most probably due to the activation of the noise protection algorithm, combined with the 'pacing on noise' parameter being programmed 'off'.This behavior complies with specifications.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, during a follow-up performed on (b)(6) 2021, it was that a non-sustained episode recorded on 19 december 2020 at 09:26 showed noise oversensing related to electromagnetic interferences (emi) on both channels.After a period of fifteen (15) short cycles, the noise algorithm was activated and a pause of pacing of around four seconds occurred.

• Brand Name: PARADYM RF
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; via crescentino s.n.; saluggia (vc), 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO; via crescentino s.n.; saluggia (vc), 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n.; saluggia (vc), 13040 ; IT 13040
• MDR Report Key: 11700775
• MDR Text Key: 246484226
• Report Number: 1000165971-2021-00401
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P060027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2014
• Device Model Number: PARADYM RF DR 9550
• Device Catalogue Number: PARADYM RF DR 9550
• Device Lot Number: 2692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2013
• 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