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

Model Number PARADYM RF VR 9250

Device Problems Failure to Interrogate (1332); Pacing Problem (1439)

Patient Problem No Information (3190)

Event Date 11/20/2019

Event Type  Injury  

Event Description

Reportedly, it was not possible to interrogate the subject icd with an inductive telemetry head.A magnet was then placed over the implant, and no response from the device was observed (no change in pacing rate).The device should be returned for analysis.

Event Description

Reportedly, it was not possible to interrogate the subject icd with an inductive telemetry head.A magnet was then placed over the implant, and no response from the device was observed (no change in pacing rate).The device should be returned for analysis.

Manufacturer Narrative

Field was modified (country was corrected).

Event Description

Reportedly, it was not possible to interrogate the subject icd with an inductive telemetry head.A magnet was then placed over the implant, and no response from the device was observed (no change in pacing rate).The device should be returned for analysis.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, it was not possible to interrogate the subject icd with an inductive telemetry head.A magnet was then placed over the implant, and no response from the device was observed (no change in pacing rate).The device should be returned for analysis.

Manufacturer Narrative

Preliminary analysis of the returned device confirmed a device failure at the level of a discrete electronic component (high voltage capacitor).

• 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
• MDR Report Key: 9461684
• MDR Text Key: 183910249
• Report Number: 1000165971-2019-00698
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• PMA/PMN Number: P060027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2015
• Device Model Number: PARADYM RF VR 9250
• Device Catalogue Number: PARADYM RF VR 9250
• Device Lot Number: 2843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/20/2019
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention