MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE

Model Number	0266
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner/outer insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.
Event or Problem Description
Boston scientific received information that this right ventricular (rv) lead dislodged.The patient has a problematic physiology, for that reason the physician decided to explant this lead and placed a new one.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• MDR Report Key: 7977550
• Report Number: 2124215-2018-16797
• Device Sequence Number: 11045724
• Product Code: NVY
• UDI-Device Identifier: 00802526431296
• UDI-Public: (01)00802526431296(17)20200423
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/23/2020
• Device Model Number: 0266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 10/18/2018
• 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; 0296; D150
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR