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

Model Number 371202

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 01/01/2014

Event Type  Death  

Manufacturer Narrative

Upon receipt, the pacemaker was visually inspected revealing no anomalies.In particular the header of the device was analysed.The set screw could be easily screwed in and out,there was no foreign material inside the header bore.All dimensions of the header bore were within the range requested by the is-1 standard specifications.Also the spring element of the pacemaker did not show any deviations.At a next step the pacemaker was interrogated and the memory content was analysed indicating no anomalies.The battery status was found to be bol.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be flawless and in amplitude and frequency as programmed.There was no indication of a device malfunction.An additional long-term pacing test was initiated.During the test, each pacing pulse was recorded.The evaluation of these pacing pulses documented regular device behavior.No intermittent or permanent loss of output was present.In summary, the device is fully functional.The analysis did not show any deviations from the technical specifications.There was no sign of a material or manufacturing problem.

Event Description

Ous mdr - it was reported to us that the patient died 1 day post implantation due to asystolic cardiac arrest.At the moment, no further details with regard to this event are available.Should we get more information, this report will be updated.Pacemaker and lead were returned to biotronik for analysis.

• Brand Name: EFFECTA SR
• Type of Device: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-12 359; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 4364497
• MDR Text Key: 12948414
• Report Number: 1028232-2014-006180
• 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: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2014

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: 371202
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2015
• Initial Date FDA Received: 12/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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): Death