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

Model Number 4269

Device Problems Connection Problem (2900); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/26/2017

Event Type  Injury  

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 Description

Boston scientific received information that during a normal change out procedure when the physician experienced difficulty loosening the atrial setscrew even with multiple troubleshooting techniques.Subsequently the right atrial (ra) lead was surgically abandoned as it was stuck in the header of the pacemaker.The pacemaker was explanted as planned.A new ra lead was successfully implanted and no adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, it was noted that the terminal segment of lead received was not in or stuck in the header.Inspection of the terminal seal rings noted no issues.Molded insulation was found to be torn, although this may have occurred during explant the cause was unable to be determined by analysis.

• 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6618825
• MDR Text Key: 76883978
• Report Number: 2124215-2017-09623
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/26/2017

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/05/2000
• Device Model Number: 4269
• Other Device ID Number: SWEET TIP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/26/2017
• Initial Date FDA Received: 06/07/2017
• Supplement Dates Manufacturer Received: 06/26/2017
• Supplement Dates FDA Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 1273; 1294; 4035; 4269
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 88 YR