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

Model Number PARADYM DR 8550

Device Problem Low impedance (2285)

Patient Problem No Information (3190)

Event Date 04/03/2015

Event Type  Injury  

Event Description

Reportedly, during a follow-up visit relative to the implanted icd system, the rv coil continuity of the icd lead was less than 200ohms and the svc coil continuity was 215ohms.It was indicated that there was also fluctuating and low ventricular lead impedance since around (b)(6) 2015.Furthermore, a stored episode, dated (b)(6) 2015, showed noise that was not inappropriately treated with shock therapy.An additional follow-up was scheduled for (b)(6) 2015 to perform echocardiography and x-ray examinations to exclude the possibility of a cardiac perforation.A re-intervention was scheduled for (b)(6) 2015.A preliminary investigation of the available patient files confirmed: fluctuations in the ventricular pacing impedance trend that started at the end of february; and oversensing in the recorded episodes dated (b)(6) 2015 that were characteristics of a potential lead issue.Recommendations in accordance with the isoline recall (issued in january 2013) have been provided.Following recommendations, a re-intervention was performed on (b)(6) 2015, no new noise was observed but still low coil impedance.The ventricular lead was capped and left in situ.The icd was also explanted and will be returned for analysis.A new system (ventricular icd lead and icd) was implanted and re-connected to the existing atrial lead.Note that the complaint relative to the lead was treated before in a separate document (refer report number: 1000165971-2015-00151) and that the subject complaint is related to the icd device.

Event Description

Reportedly, during a follow-up visit relative to the implanted icd system, the rv coil continuity of the icd lead was less than 200ohms and the svc coil continuity was 215ohms.It was indicated that there was also fluctuating and low ventricular lead impedance since around (b)(6) 2015.Furthermore, a stored episode, dated (b)(6) 2015, showed noise that was not inappropriately treated with shock therapy.An additional follow-up was scheduled for (b)(6) 2015 to perform echocardiography and x-ray examinations to exclude the possibility of a cardiac perforation.A re-intervention was scheduled for (b)(6) 2015.A preliminary investigation of the available patient files confirmed: fluctuations in the ventricular pacing impedance trend that started at the end of (b)(6); and oversensing in the recorded episodes dated (b)(6) 2015 that were characteristics of a potential lead issue.Recommendations in accordance with the isoline recall (issued in (b)(6) 2013) have been provided.Following recommendations, a re-intervention was performed on (b)(6) 2015, no new noise was observed but still low coil impedance.The ventricular lead was capped and left in situ.The icd was also explanted and will be returned for analysis.A new system (ventricular icd lead and icd) was implanted and re-connected to the existing atrial lead.Note that the complaint relative to the lead was treated before in a separate document (refer report number: 1000165971-2015-00151) and that the subject complaint is related to the icd device.

Manufacturer Narrative

Preliminary analysis of the returned device did not reveal any anomaly.

Event Description

Reportedly, during a follow-up visit relative to the implanted icd system, the rv coil continuity of the icd lead was less than 200ohms and the svc coil continuity was 215ohms.It was indicated that there was also fluctuating and low ventricular lead impedance since around (b)(6) 2015.Furthermore, a stored episode, dated (b)(6) 2015, showed noise that was not inappropriately treated with shock therapy.An additional follow-up was scheduled for (b)(6) 2015 to perform echocardiography and x-ray examinations to exclude the possibility of a cardiac perforation.A re-intervention was scheduled for (b)(6) 2015.A preliminary investigation of the available patient files confirmed: fluctuations in the ventricular pacing impedance trend that started at the end of (b)(6); and oversensing in the recorded episodes dated (b)(6) 2015 that were characteristics of a potential lead issue.Recommendations in accordance with the isoline recall (issued in january 2013) have been provided.Following recommendations, a re-intervention was performed on (b)(6) 2015, no new noise was observed but still low coil impedance.The ventricular lead was capped and left in situ.The icd was also explanted and will be returned for analysis.A new system (ventricular icd lead and icd) was implanted and re-connected to the existing atrial lead.Note that the complaint relative to the lead was treated before in a separate document (refer report number: 1000165971-2015-00151) and that the subject complaint is related to the icd device.

• Brand Name: PARADYM
• 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 9214 0; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 4683690
• MDR Text Key: 6061003
• Report Number: 1000165971-2015-00216
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PP980049
• 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: 04/06/2015

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: Physician
• Device Expiration Date: 08/07/2012
• Device Model Number: PARADYM DR 8550
• Device Catalogue Number: PARADYM DR 8550
• Device Lot Number: 2549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/06/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 04/13/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/28/2015; 06/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2011
• 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): Required Intervention