MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY ORCHESTRA; PROGRAMMER, PACEMAKER

Model Number ORCHESTRA PLUS

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem Electric Shock (2554)

Event Date 05/12/2017

Event Type  Injury  

Event Description

Reportedly, when pressing the power button to turn the programmer on prior to a follow-up, the user received electrical impulses in the form of a minor shock.The programmer was returned for analysis.Preliminary analysis revealed that one screw was detached from the etx board (for unknown reasons) and was moving freely below the carrier board.The most probable hypothesis to explain the reported behavior is that the screw was blocked under the psu, in contact with the conductive painting of the lower shell.As the user turned the programmer on, the screw made a short circuit towards the ground, and the whole programmer was brought to the supply voltage.This lasted for the instant before the fuse burnt, disconnecting the programmer from power supply.

Manufacturer Narrative

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

Event Description

Reportedly, when pressing the power button to turn the programmer on prior to a follow-up, the user received electrical impulses in the form of a minor shock.The programmer was returned for analysis.Preliminary analysis revealed that one screw was detached from the etx board (for unknown reasons) and was moving freely below the carrier board.The most probable hypothesis to explain the reported behavior is that the screw was blocked under the psu, in contact with the conductive painting of the lower shell.As the user turned the programmer on, the screw made a short circuit towards the ground, and the whole programmer was brought to the supply voltage.This lasted for the instant before the fuse burnt, disconnecting the programmer from power supply.

• Brand Name: ORCHESTRA
• Type of Device: PROGRAMMER, PACEMAKER
• 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): KONTRON SUDETENSTR. 8 87600 KAUFBEUREN GERMANY; 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: 6642727
• MDR Text Key: 77614037
• Report Number: 1000165971-2017-00477
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORCHESTRA PLUS
• Device Catalogue Number: ORCHESTRA PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/24/2017
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention