MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	REPLY DR
Medical Device Problem Codes	Nonstandard Device (1420); Incorrect Device Or Component Shipped (2962)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportedly, on (b)(6) 2018, usa crm technical services was informed that the as-shipped polarities of the subject pacemaker were unipolar instead of bipolar.As reply pacemakers are designed to prevent polarity reprogramming from unipolar to bipolar without normal lead impedance measurement, the polarity cannot be reprogrammed before implantation.
Additional Manufacturer Narrative
Please refer to the attached analysis report.
Event or Problem Description
Reportedly, on (b)(6) 2018, usa crm technical services was informed that the as-shipped polarities of the subject pacemaker were unipolar instead of bipolar.As reply pacemakers are designed to prevent polarity reprogramming from unipolar to bipolar without normal lead impedance measurement, the polarity cannot be reprogrammed before implantation.

• Brand Name: REPLY
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• MDR Report Key: 7604493
• Report Number: 1000165971-2018-00570
• Device Sequence Number: 1396332
• Product Code: NVZ
• UDI-Device Identifier: 08031527011523
• UDI-Public: (01)08031527011523(11)171102(17)190602
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P950029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2019
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: S0291
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/07/2018
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1