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

Model Number 356254

Device Problem Intermittent Capture (1080)

Patient Problem Dizziness (2194)

Event Date 10/30/2014

Event Type  malfunction  

Event Description

Ous mdr - after an implantation period of about 100 months, an intermittent loss of capture was reported.The pacemaker was explanted and returned to biotronik for analysis.A new system was implanted.Apart from dizziness throughout the last year, no further adverse patient side effects have been reported.

Manufacturer Narrative

The pacemaker was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this pacemaker were re-investigated.All production steps had been performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.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 elements of the pacemaker did not show any deviations.At a next step the pacemaker was interrogated and the pacemaker¿s memory content was analysed indicating no anomalies.The battery status was found to be eri since (b)(6) 2014.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 behaviour.No intermittent or permanent loss of output was present.The amount of charge taken from the battery was verified.After an implantation duration of 101 months, the battery condition was anticipated.In summary, the device is fully functional.With regard to the issues as mentioned in the complaint description, the analysis did not show any deviations from the technical specifications.The battery condition was found to be anticipated.The analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: TALOS 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: 4332891
• MDR Text Key: 5221622
• Report Number: 1028232-2014-006041
• 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: 12/01/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 356254
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 12/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2006
• 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