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

Model Number	6937A-35
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	07/16/2016
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 right ventricular (rv) lead triggered a lead integrity alert (lia) due to increased counts to the sensing integrity counter (sic) and high rate non-sustained episodes.Noise was observed on the transmission.The patient reportedly has experienced inappropriate therapy in the past due to oversensing and noise.The rv lead remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter.Analysis of the device memory ind icated the impedance of the right ventricular defibrillation coil was beyond the expected upper range.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that impedance spikes and variable impedance values were observed on the rv lead.

• 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: 8633449
• Report Number: 2649622-2019-08771
• Device Sequence Number: 13866813
• Product Code: LWS
• UDI-Device Identifier: 00613994492388
• UDI-Public: 00613994492388
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P980050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2019

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: 09/27/2014
• Device Model Number: 6937A-35
• Device Catalogue Number: 6937A-35
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 07/02/2019; 07/09/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 07/09/2019; 07/10/2019
• 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: D314VRG ICD, 4968-35 LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 11 YR