MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF; DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)

Model Number PARADYM RF SONR CRT-D 9770

Device Problem Over-Sensing (1438)

Patient Problem Shock (2072)

Event Date 09/14/2016

Event Type  malfunction  

Event Description

During a planned follow up on (b)(6) 2016, device memories were checked and it was observed that the patient received an inappropriate shock on (b)(6) 2016 (she did not feel the shock).The rv lead measurements (detection curve) have shown a huge drop in (b)(6) and there were several episodes with noises that tend to prove that the rv lead was broken.Therefore the doctor has decided to replace the lead (exact date is unknown).The physician asked for an analysis about remaining longevity of the battery voltage.The battery curve showed a drop just after the shock.Based on the preliminary analysis, rv lead issue or a lead/defibrillator connection issue is suspected.No anomaly is suspected regarding the icd.Patient care recommendations were provided (to replace the rv lead and check the battery voltage).

Manufacturer Narrative

Following recommendation, the device was explanted and will be returned for analysis.

Event Description

During a planned follow up on (b)(4) 2016, device memories were checked and it was observed that the patient received an inappropriate shock on (b)(4) 2016 (she did not feel the shock).The rv lead measurements (detection curve) have shown a huge drop in june and there were several episodes with noises that tend to prove that the rv lead was broken.Therefore the doctor has decided to replace the lead (exact date is unknown).The physician asked for an analysis about remaining longevity of the battery voltage.The battery curve showed a drop just after the shock.Based on the preliminary analysis, rv lead issue or a lead/defibrillator connection issue is suspected.No anomaly is suspected regarding the icd.Patient care recommendations were provided (to replace the rv lead and check the battery voltage).

Manufacturer Narrative

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

Event Description

During a planned follow up on (b)(6) 2016, device memories were checked and it was observed that the patient received an inappropriate shock on (b)(6) 2016 (she did not feel the shock).The rv lead measurements (detection curve) have shown a huge drop in (b)(6) and there were several episodes with noises that tend to prove that the rv lead was broken.Therefore the doctor has decided to replace the lead (exact date is unknown).The physician asked for an analysis about remaining longevity of the battery voltage.The battery curve showed a drop just after the shock.Based on the preliminary analysis, rv lead issue or a lead/defibrillator connection issue is suspected.No anomaly is suspected regarding the icd.Patient care recommendations were provided (to replace the rv lead and check the battery voltage).

Manufacturer Narrative

(b)(4).

Event Description

During a planned follow up on (b)(6) 2016, device memories were checked and it was observed that the patient received an inappropriate shock on (b)(6) 2016 (she did not feel the shock).The rv lead measurements (detection curve) have shown a huge drop in june and there were several episodes with noises that tend to prove that the rv lead was broken.Therefore the doctor has decided to replace the lead (exact date is unknown).The physician asked for an analysis about remaining longevity of the battery voltage.The battery curve showed a drop just after the shock.Based on the preliminary analysis, rv lead issue or a lead/defibrillator connection issue is suspected.No anomaly is suspected regarding the icd.Patient care recommendations were provided (to replace the rv lead and check the battery voltage).

• Brand Name: PARADYM RF
• Type of Device: DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)
• 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: 6016732
• MDR Text Key: 57552416
• Report Number: 1000165971-2016-00623
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2013
• Device Model Number: PARADYM RF SONR CRT-D 9770
• Device Catalogue Number: PARADYM RF SONR CRT-D 9770
• Device Lot Number: 2657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/14/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 10/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 09/15/2017
• Supplement Dates FDA Received: 11/22/2016; 12/19/2016; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2012
• 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