MAUDE Adverse Event Report: CPI - DEL CARIBE SWEET TIP; IMPLANTABLE LEAD

Model Number 4269

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2016

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the device header was examined.Visual inspection noted that the ra ring, ra tip and rv ring retainer washer were "volcanoed" and a wrench tip was broke off in the setscrews.The ra ring and tip retainer washers were removed but due to the damage the setscrews were unable to be removed.The back of the header was cut to expose the lead tip to see if lead was stuck.The lead tip was able to be backed out without any issue.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing and sensing functions were tested.The device operated appropriately, according to its performance specifications with no interruptions in therapy output or programmer communication at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.

Event Description

Boston scientific received information that during a change out procedure the associated right atrial (ra) lead was not able to be removed from the header of this device.The ra set screws were unable to be loosened.Both products were removed from service.The device has been returned for analysis.There were no adverse patient effects reported.

• Brand Name: SWEET TIP
• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5641469
• MDR Text Key: 45136718
• Report Number: 2124215-2016-07671
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2016

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/20/1999
• Device Model Number: 4269
• Other Device ID Number: SWEET TIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 76 YR