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

Model Number PLATINIUM VR 1210

Device Problems High impedance (1291); Device Slipped (1584); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 02/15/2017

Event Type  Injury  

Event Description

Reportedly, during a scheduled follow-up visit on (b)(6) 2016, a high impedance >3000 ohms on right ventricular coil was detected.All other measurements were normal.This abnormal high impedance resulted in a revision of the icd lead on (b)(6) 2016.The post procedure follow up on the next day showed sensing values around 0.3 - 1.7 mv as well as sensing of the atrium contraction.So they decided to explant the whole system and implanted a new system on (b)(6) 2017.During the explant procedure they recognized a loose suture of the lead and a dislocation of the lead.Nevertheless the reporter asked for investigation of the device and lead.The subject icd will be returned for analysis.

Manufacturer Narrative

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

Event Description

Reportedly, during a scheduled follow-up visit on (b)(6) 2016, a high impedance >3000 ohms on right ventricular coil was detected.All other measurements were normal.This abnormal high impedance resulted in a revision of the icd lead on (b)(6) 2016.The post procedure follow up on the next day showed sensing values around 0.3 - 1.7 mv as well as sensing of the atrium contraction.So they decided to explant the whole system and implanted a new system on (b)(6) 2017.During the explant procedure they recognized a loose suture of the lead and a dislocation of the lead.Nevertheless the reporter asked for investigation of the device and lead.The subject icd will be returned for analysis.

Event Description

Reportedly, during a scheduled follow-up visit on (b)(6) 2016, a high impedance >3000 ohms on right ventricular coil was detected.All other measurements were normal.This abnormal high impedance resulted in a revision of the icd lead on (b)(6) 2016.The post procedure follow up on the next day showed sensing values around 0.3 - 1.7 mv as well as sensing of the atrium contraction.So they decided to explant the whole system and implanted a new system on (b)(6) 2017.During the explant procedure they recognized a loose suture of the lead and a dislocation of the lead.Nevertheless the reporter asked for investigation of the device and lead.The subject icd will be returned for analysis.

• 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: 6408833
• MDR Text Key: 70061013
• Report Number: 1000165971-2017-00212
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527014357
• UDI-Public: (01)08031527014357(11)160907(17)180407
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2018
• Device Model Number: PLATINIUM VR 1210
• Device Catalogue Number: PLATINIUM VR 1210
• Device Lot Number: S0212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/22/2017
• Event Location: Hospital
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2016
• 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
• Patient Outcome(s): Required Intervention