MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EFFECTA DR; PACEMAKER

Model Number 371199

Device Problem Connection Problem (2900)

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

Event Date 05/17/2017

Event Type  malfunction  

Event Description

Ous mdr - the atrial screw could not be tightened with a torque wrench on this device.

Manufacturer Narrative

After its return, the pacemaker underwent a status interrogation, and the memory content was analyzed.The analysis of the memory content showed proper device behavior.In a next step, the pacemaker was visually inspected, and the connection system was examined.Minor damage was found at the plate screw, as well as a slightly rounded thread of the plate screw.This indicates the impact of a strong external force during the operation.The plate screw could be tightened without problems during the analysis.The screws and the spring elements of the lead connections were without defects.Leads inserted as a test could be contacted with easy passage, low-ohm values, and reliably.The drill hole dimensions were all within the dimensions defined by the is-1 standard.The pacemakers capability to provide therapy was tested.The antibradycardic output signal matched the programmed values, and the signal sensing of the device was normal.The pacemaker showed specification-conforming behavior in regard to its device functions.In summary, the device was without defects during the analysis and within specifications both regarding the connection system and the electronics.There was no material defect or manufacturing error.

• Brand Name: EFFECTA DR
• 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: 6659769
• MDR Text Key: 78154610
• Report Number: 1028232-2017-02145
• 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
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2017

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 Model Number: 371199
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 06/22/2017
• Supplement Dates Manufacturer Received: 07/11/2017
• Supplement Dates FDA Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2017
• 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): Hospitalization