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

Model Number	6937A-65
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: model: 1258t86, st.Jude lead; implanted: (b)(6) 2016.
Event or Problem Description
It was reported by a healthcare professional (hcp) that a lead revision was completed.The hcp was unable to determine which lead(s) were revised from the operative notes.The high voltage svc lead remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRANSVENE CS/SVC
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6162616
• Report Number: 2649622-2016-15223
• Device Sequence Number: 13518447
• Product Code: LWS
• UDI-Device Identifier: 00643169535992
• UDI-Public: 00643169535992
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2016

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: 01/11/2018
• Device Model Number: 6937A-65
• Device Catalogue Number: 6937A-65
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2016
• Supplement Date Received by Manufacturer: 09/06/2016
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 09/26/2017
• 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: DVBB1D1, ICD / 7122-65, ST. JUDE LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR