MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE

Model Number	0266
Medical Device Problem Codes	Failure to Capture (1081); Capturing Problem (2891); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Syncope (1610)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
Boston scientific received information that the patient this right ventricular (rv) lead and associated device experienced syncope.The system displayed a rise in pacing threshold measurements and intermittent loss of capture (loc) which, at times, induced ventricular tachycardia (vt).The vt was terminated with anti-tachycardia pacing (atp).It was reported that the system and patient would continued to be monitored.
Event or Problem Description
Subsequently the patient was seen for a revision procedure where the lead was surgically abandoned and replaced.The device was explanted.There were no additional adverse patient effects.

• Brand Name: ENDOTAK RELIANCE
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• MDR Report Key: 6503961
• Report Number: 2124215-2017-06150
• Device Sequence Number: 495294
• Product Code: NVY
• UDI-Device Identifier: 00802526431296
• UDI-Public: (01)00802526431296(17)20150415
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2017

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: 04/15/2015
• Device Model Number: 0266
• Other Device ID Number: RELIANCE 4-SITE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 07/19/2017
• 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: 0266; 4470; E142
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR