MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SELUTE PICOTIP; IMPLANTABLE LEAD

Model Number 4034

Device Problems Signal Artifact/Noise (1036); Pacing Problem (1439); Difficult to Remove (1528); Connection Problem (2900)

Patient Problem No Code Available (3191)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during the change out procedure of this patients existing pacemaker, the right ventricular (rv) lead was stuck in the header of the device.Observations of noise and pacing inhibition with no asystole were observed on the rv lead once connected to the new device.Pocket manipulation was performed which also replicated the noise.Subsequently, the rv lead was surgically abandoned and replaced.A new rv lead was successfully implanted.No additional adverse patient effects were reported.

• Brand Name: SELUTE PICOTIP
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10775716
• MDR Text Key: 214314911
• Report Number: 2124215-2020-23150
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950001/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2020

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: 02/18/2001
• Device Model Number: 4034
• Device Catalogue Number: 4034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 11/02/2020
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR