MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ NAVLINK MODULE; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number	H420995
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During device preparation for a supraventricular tachycardia procedure, an error message appeared stating the neck patch was disconnected and the procedure was cancelled.The connections for the navlink and patches were verified and appeared correct.The neck and chest patches were replaced with no resolution.A replacement navlink was unavailable and the procedure was rescheduled.There were no adverse consequences to the patient due to the cancellation.
Additional Manufacturer Narrative
No case study files or product was returned for investigation and no further information is available.Based on the information provided to abbott and the service report from 16aug18, the navlink identified an error on channel 5 during the patch impedance test.The navlink was replaced and passed all testing.Review of inspection results for this lot number confirmed that no non-conformances were identified related to the reported event and the product met abbott specifications.

• Brand Name: ENSITE VELOCITY¿ NAVLINK MODULE
• Common Device Name: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 7828765
• Report Number: 2184149-2018-00140
• Device Sequence Number: 19284903
• Product Code: DQK
• UDI-Device Identifier: 05414734209953
• UDI-Public: 05414734209953
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K160187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: H420995
• Device Lot Number: G904877
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 12/03/2018
• 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: Other