MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ENTOVIS DR-T PROMRI; PACEMAKER

Model Number 371992

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device, and review of verification and validation testing of the associated manufacturing and sterility processes.The manufacturing process for this device was re-investigated.There was no sign of any inconsistency during the manufacturing process which might be related to an adverse clinical observation.All production steps had been performed accordingly, including packaging and sterilization.The product was sterilized by eto per a validated method demonstrated to yield a sterility assurance level (sal) of 1 x 10-6 ((b)(4)).The sterile barrier has been demonstrated to be intact up to 46 months after storage in real time aging conditions, as determined for product with the same packaging and sterility parameters (reference: (b)(4)).In summary, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.It is presumed that if the sterile barrier was intact up to the time of implant, sterility would not be compromised.

Event Description

Ous mdr - this device was implanted one day past the use before date.There were no adverse patient side effects reported.

• Brand Name: ENTOVIS DR-T PROMRI
• Type of Device: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 6234672
• MDR Text Key: 64238778
• Report Number: 1028232-2016-05229
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2016

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 Model Number: 371992
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• 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