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

Model Number PLATINIUM VR 1240

Device Problem Wireless Communication Problem (3283)

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

Event Date 05/19/2017

Event Type  malfunction  

Event Description

The subject icd was implanted on (b)(6) 2017.Reportedly, during the induction test using 30 hz pacing performed at implant, the rf connection was lost and could not be retrieved.Even though the induction test could not be checked in real time, it was reported that the test succeeded and that a shock was delivered after normal vf detection and charge time.Reportedly, after the induction test, it was not possible to refresh the episodes due to a programmer freeze.A restart of the programmer and re-interrogation of the icd were needed.Reportedly, the distance between the rf head and the icd was around 2m in light upper position at the foot end of the operation table.Lots of electrical equipments and around 6 people with x-ray protection were present in the room.

Manufacturer Narrative

Preliminary analysis showed that rf communication was most likely disturbed by environmental conditions.The reported absence of episodes was due to an inadequate management at programmer software level.

Event Description

The subject icd was implanted on (b)(6) 2017.Reportedly, during the induction test using 30 hz pacing performed at implant, the rf connection was lost and could not be retrieved.Even though the induction test could not be checked in real time, it was reported that the test succeeded and that a shock was delivered after normal vf detection and charge time.Reportedly, after the induction test, it was not possible to refresh the episodes due to a programmer freeze.A restart of the programmer and re-interrogation of the icd were needed.Reportedly, the distance between the rf head and the icd was around 2m in light upper position at the foot end of the operation table.Lots of electrical equipments and around 6 people with x-ray protection were present in the room.

Manufacturer Narrative

(b)(4).

Event Description

The subject icd was implanted on (b)(6) 2017.Reportedly, during the induction test using 30 hz pacing performed at implant, the rf connection was lost and could not be retrieved.Even though the induction test could not be checked in real time, it was reported that the test succeeded and that a shock was delivered after normal vf detection and charge time.Reportedly, after the induction test, it was not possible to refresh the episodes due to a programmer freeze.A restart of the programmer and re-interrogation of the icd were needed.Reportedly, the distance between the rf head and the icd was around 2m in light upper position at the foot end of the operation table.Lots of electrical equipments and around 6 people with x-ray protection were present in the room.

• 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
• 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: 6633469
• MDR Text Key: 77514603
• Report Number: 1000165971-2017-00471
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P980049
• 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,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2017
• Device Model Number: PLATINIUM VR 1240
• Device Catalogue Number: PLATINIUM VR 1240
• Device Lot Number: S0180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/19/2017
• Event Location: Hospital
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2016
• 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