MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SLX 58/13 BP; PACING LEAD

Model Number	333900
Medical Device Problem Codes	Failure to Capture (1081); Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Lead was explanted and replaced due to high impedances.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
On 7/15/2019 the hospital filed a report with the fda (b)(4) and indicated that there was loss of capture and a possible fracture of this lead.Upon receipt, the lead under complaint was found cut 56cm distal to the is-1 connector pin.Only the proximal lead fragment was returned and subjected to an extensive analysis.The visual inspection showed severe explantation damages such as a torn off connector pin and a damaged yoke.The lead tip was found damaged with an elongated inner conductor coil.In addition, several cuts in the insulation and deformations of the inner and outer conductor coils were detected.As the root cause of the observed damages, tensile and mechanical forces applied during the extraction procedure should be taken into consideration.Due to the extent of the damages a mechanical and electrical analysis of the lead was not properly feasible.With regard to the issues mentioned in the complaint description, the analysis of the lead fragment did not show any deviations.The manufacturing process for this lead 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: SLX 58/13 BP
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8689242
• Report Number: 1028232-2019-02318
• Device Sequence Number: 3030348
• Product Code: DTB
• UDI-Device Identifier: 04035479049218
• UDI-Public: 04035479049218
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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 Model Number: 333900
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 09/18/2019
• 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
• Patient Age: 87 YR