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

Model Number 4294

Device Problems Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877); Device Contamination With Biological Material (2908)

Patient Problem Dizziness (2194)

Event Date 08/20/2017

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 this right ventricular (rv) lead had evidence of oversensed noise which could be reproduced with pocket manipulation.The patient reported feeling dizzy.The patient has complete heart block and is pacemaker dependent.The rv sensitivity was reprogrammed and the patient was referred to their implanting physician for further assessment.The implanting physician elected to revise the pacemaker system.Upon opening the pocket, the device-to-lead connections were assessed and confirmed appropriate.Attempts to create noise with pocket and lead manipulation was unsuccessful.Upon disconnecting the rv lead the physician noted a small amount of debris on the proximal electrode.The leads were tested with the pacing system analyzer (psa) and all measurements were appropriate.The physician elected to explant the device and keep the leads in service.Following the procedure, there was no evidence of noise observed through the new device.

• Brand Name: SELUTE
• 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: 6969165
• MDR Text Key: 89969178
• Report Number: 2124215-2017-19424
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/02/2000
• Device Model Number: 4294
• Other Device ID Number: SELUTE AJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/20/2017
• 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
• Treatment: 1274; 1291; 4035; 4136; 4294; K289
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR