MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SAFIO S 60; PACING LEAD

Model Number	370946
Medical Device Problem Codes	Break (1069); Over-Sensing (1438); Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, it was reported to (b)(6) hospital from (b)(6) hospital that there was a noise in the rv lead.On (b)(6) 2021, explantation was performed.During interrogation, ventricular sensing was set to unipolar and sensitivity was set to 7.5 mv, and noise was constantly confirmed in real time.There is a part that oversenses even with a dull sensitivity setting, thus it changed to an external cardiac pacemaker because it was a complete atrioventricular block (chb).After device explantation, psa measurement was performed and the resistance value was around 180 ohms (it was confirmed there might be a lead coating damage.) the operation was completed.The physician suspects the device malfunction.
Additional Manufacturer Narrative
Upon receipt the lead was found cut 6.5cm distal to the is-1 connector pin and 48cm proximal to the lead tip.A medial part was not returned.The performance of the returned fragments was scrutinized, including a visual inspection.The inspection revealed severe abrasion marks at several positions of the lead segments.In particular 3cm proximal to the lead tip abrasion marks were detected on the outer insulation and the inner insulation was found abraded through and a short circuit was measured.This damage is assumed to be the root cause for the observed oversensing.Based on the characteristics of this damage, it is reasonable to assume that the lead had been subject to severe mechanical stress in the implanted state.Significant lead motion in the area of the tricuspid valve and interaction with atypical tissues should be taken into consideration.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: SAFIO S 60
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11229470
• Report Number: 1028232-2021-00452
• Device Sequence Number: 14330809
• Product Code: NVN
• UDI-Device Identifier: 04035479113957
• UDI-Public: 04035479113957
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

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: 05/31/2016
• Device Model Number: 370946
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Received by Manufacturer: 01/24/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 07/23/2021
• 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