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

Model Number	6937A-58
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2019
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 right ventricular (rv) lead triggered a lead integrity alert (lia) for oversensing of noise with high rate non-sustained and sensing integrity counter (sic) episodes.The lead was reprogrammed and continues to be monitored.The lead remains in use.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 indicated oversensing due to non-physiologic signals/sensing integrity counter.Analysis of the device memory indicated the criteria for the right ventricular lead integrity alert were met.Analysis of the device memory indicated oversensing due to electromagnetic interference/noise.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: 9970550
• Report Number: 2649622-2020-07733
• Device Sequence Number: 4483661
• Product Code: LWS
• UDI-Device Identifier: 00613994492418
• UDI-Public: 00613994492418
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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: 09/11/2015
• Device Model Number: 6937A-58
• Device Catalogue Number: 6937A-58
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 04/24/2020
• 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: Required Intervention
• Patient Age: 5 YR
• Patient Weight: 21