MAUDE Adverse Event Report: CPI - DEL CARIBE FINELINE II; IMPLANTABLE LEAD

Model Number 4469

Device Problems Device Alarm System (1012); High impedance (1291); Ambient Noise Problem (2877)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

At this time, the lead remains in service.If additional information is received, this report will be updated.

Event Description

Boston scientific received information that the patient with this right atrial (ra) lead heard their device beeping due to high ra lead impedance measurements of greater than 2500 ohms.There was also noise on the ra channel when the patient moved their arm; however, the patient did not require atrial pacing.During the in-office interrogation, lead impedance measurements were normal.The device was reprogrammed and the patient would continue to be monitored.No adverse patient effects were reported.The lead remains in service.

• Brand Name: FINELINE II
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 6700262
• MDR Text Key: 79586859
• Report Number: 2124215-2017-07860
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00802526265143
• UDI-Public: (01)00802526265143(17)20161104
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960004/S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/04/2016
• Device Model Number: 4469
• Other Device ID Number: FINELINE II EZ STEROX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0292; 4469; E142
• Patient Age: 55 YR