MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SAFIO S 53; PACING LEAD

Model Number	370945
Medical Device Problem Code	Intermittent Capture (1080)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that approx.72 months after the implantation intermittent loss of capture (atrial) was noted.Patient received a complete new system.
Additional Manufacturer Narrative
The lead was not returned for analysis.However, the manufacturing process for the lead as well as for the pacemaker was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process which may be related to the clinical observation.Upon receipt, the pacemaker was interrogated and the memory content was analyzed indicating no anomalies.The header of the device was analyzed.The set screws could be easily screwed in and out, there was no foreign material inside the header bores.All dimensions of the header bores were within the range requested by the standard specifications.Also the spring elements of the pacemaker did not show any deviations.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal 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.There was no intermittent or permanent loss of output.In conclusion, the analysis did not show any deviations from the technical specifications.The analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: SAFIO S 53
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10099332
• Report Number: 1028232-2020-02197
• Device Sequence Number: 11609788
• Product Code: NVN
• UDI-Device Identifier: 04035479113940
• UDI-Public: 04035479113940
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: 12/31/2015
• Device Model Number: 370945
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization