MAUDE Adverse Event Report: SORIN CRM SYMPHONY; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number RHAPSODY + DR 2530

Device Problem Pacing Inadequately (1442)

Patient Problems Bacterial Infection (1735); Shock (2072); Electric Shock (2554)

Event Date 05/26/2017

Event Type  Injury  

Event Description

The subject device was programmed in ddd at 60 bpm on (b)(6) 2017 but physician reportedly saw spikes and paced rhythm at 45 bpm on the ecg trace.The impedance was around 300 ohm (no trend available).In ddi at 30 bpm, there was a completely dissociated a - v rhythm.Spike releases seemed to capture only few times (the threshold was not clear even after increasing the frequency of stimulation up to 120 bpm).When the device was programmed in vvi mode at 70 bpm and then 80 bpm, it continued to release spikes at 45 bpm, when programmed in vvi 90 bpm the device paced at 90 bpm but only half of the stimulation was effective.Same behavior programming the stimulation with the bipolar configuration of leads.It seemed like it was always programmed in voo 45 bpm.Note that in the previous days (date unknown), the patient received several dc shock in the hospital.

Manufacturer Narrative

Preliminary analysis of returned device showed that the device works normally without any problem.

Event Description

The subject device was programmed in ddd at 60bpm on (b)(6) 2017 but physician reportedly saw spikes and paced rhythm at 45bpm on the ecg trace.The impedance was around 300ohm (no trend available).In ddi at 30bpm, there was a completely dissociated a - v rhythm.Spike releases seemed to capture only few times (the threshold was not clear even after increasing the frequency of stimulation up to 120bpm).When the device was programmed in vvi mode at 70bpm and then 80bpm, it continued to release spikes at 45 bpm, when programmed in vvi 90bpm the device paced at 90bpm but only half of the stimulation was effective.Same behavior programming the stimulation with the bipolar configuration of leads.It seemed like it was always programmed in voo 45bpm.Note that in the previous days (date unknown), the patient received several dc shock in the hospital.In addition, the patient is infectious, affected by klebsiella.

Event Description

The subject device was programmed in ddd at 60bpm on (b)(6) 2017 but physician reportedly saw spikes and paced rhythm at 45bpm on the ecg trace.The impedance was around 300ohm (no trend available).In ddi at 30bpm, there was a completely dissociated a - v rhythm.Spike releases seemed to capture only few times (the threshold was not clear even after increasing the frequency of stimulation up to 120bpm).When the device was programmed in vvi mode at 70bpm and then 80bpm, it continued to release spikes at 45 bpm, when programmed in vvi 90bpm the device paced at 90bpm but only half of the stimulation was effective.Same behavior programming the stimulation with the bipolar configuration of leads.It seemed like it was always programmed in voo 45bpm.Note that in the previous days (date unknown), the patient received several dc shock in the hospital.In addition, the patient is infectious, affected by klebsiella.

Manufacturer Narrative

Review of the real time tests performed on (b)(6) 2017 confirmed that the subject pacemaker was properly pacing at that time.

Event Description

The subject device was programmed in ddd at 60bpm on (b)(6) 2017 but physician reportedly saw spikes and paced rhythm at 45bpm on the ecg trace.The impedance was around 300ohm (no trend available).In ddi at 30bpm, there was a completely dissociated a - v rhythm.Spike releases seemed to capture only few times (the threshold was not clear even after increasing the frequency of stimulation up to 120bpm).When the device was programmed in vvi mode at 70bpm and then 80bpm, it continued to release spikes at 45 bpm, when programmed in vvi 90bpm the device paced at 90bpm but only half of the stimulation was effective.Same behavior programming the stimulation with the bipolar configuration of leads.It seemed like it was always programmed in voo 45bpm.Note that in the previous days (date unknown), the patient received several dc shock in the hospital.In addition, the patient is infectious, affected by (b)(6).

Manufacturer Narrative

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

Event Description

The subject device was programmed in ddd at 60bpm on (b)(6) 2017 but physician reportedly saw spikes and paced rhythm at 45bpm on the ecg trace.The impedance was around 300ohm (no trend available).In ddi at 30bpm, there was a completely dissociated a - v rhythm.Spike releases seemed to capture only few times (the threshold was not clear even after increasing the frequency of stimulation up to 120bpm).When the device was programmed in vvi mode at 70bpm and then 80bpm, it continued to release spikes at 45 bpm, when programmed in vvi 90bpm the device paced at 90bpm but only half of the stimulation was effective.Same behavior programming the stimulation with the bipolar configuration of leads.It seemed like it was always programmed in voo 45bpm.Note that in the previous days (date unknown), the patient received several dc shock in the hospital.In addition, the patient is infectious, affected by klebsiella.

• Brand Name: SYMPHONY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): SORIN CRM; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer (Section G): SORIN CRM 98, RUE MAURICE ARNOUX 92120 MONTROUGE FRANCE; 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: 6662912
• MDR Text Key: 78250259
• Report Number: 1000165971-2017-00510
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2005
• Device Model Number: RHAPSODY + DR 2530
• Device Catalogue Number: RHAPSODY + DR 2530
• Device Lot Number: S040212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/29/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/29/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: Not provided; 08/17/2017; 09/29/2017; 01/29/2018
• Supplement Dates FDA Received: 06/26/2017; 09/08/2017; 10/27/2017; 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2004
• 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
• Patient Outcome(s): Life Threatening; Required Intervention