MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE

Model Number	0265
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
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 from the warranty department that this local representative was contacted by a hospital staff member via phone message.The staff member was inquiring about boston scientific's indigent program.The patient was hospitalized and has no insurance.The patient has a non-boston scientific device and a boston scientific lead that has malfunction.The physician intends to replace the implant lead and the hospital was looking for an indigent donation.No patient name or implanted product information was provided to the local representative.The specific lead malfunction was not identified and the lead currently remains in-service.The local representative was transferred to the person in customer services who coordinates the indigent program.Boston scientific received information that the local representative was able to identify the patient name and model#/sn# of the implantable right ventricular (rv) defibrillation lead.According to the local representative, this rv defibrillation lead was exhibiting high rv pacing impedance and electrogram noise.The physician suspects a lead conductor fracture.The local representative has not been notified of a scheduled rv defibrillation lad replacement procedure.The available information suggests that this rv defibrillation lead remains in-service.

• Brand Name: ENDOTAK RELIANCE
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• MDR Report Key: 6701061
• Report Number: 2124215-2017-11531
• Device Sequence Number: 11266070
• Product Code: NVY
• UDI-Device Identifier: 00802526431289
• UDI-Public: (01)00802526431289(17)20150214
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/14/2015
• Device Model Number: 0265
• Other Device ID Number: RELIANCE 4-SITE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 07/11/2017
• 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: 0265
• Patient Age: 68 YR