MAUDE Adverse Event Report: MPRI TRANSVENE CS/SVC LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	6937A-35
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the lead integrity alert (lia) triggered, and the pace/sense right ventricular (rv) lead exhibited possible oversensing and an increased sensing integrity counter (sic).Additionally, the high voltage rv lead exhibited high/undefined impedances.It was suspected that both leads had fractured.The leads were capped and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRANSVENE CS/SVC LEAD
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8975271
• Report Number: 2649622-2019-16181
• Device Sequence Number: 189374
• Product Code: LWS
• UDI-Device Identifier: 00613994492388
• UDI-Public: 00613994492388
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P980050
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/09/2016
• Device Model Number: 6937A-35
• Device Catalogue Number: 6937A-35
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DDBB1D1 ICD, 4968-25 X2 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 12 YR