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

Model Number 7741

Device Problems Pacing Problem (1439); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Emotional Changes (1831); Scar Tissue (2060); Complaint, Ill-Defined (2331); Depression (2361); Post Operative Wound Infection (2446)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.

Event Description

Boston scientific received information that the patient implanted with this pacemaker, right atrial (ra) and right ventricular (rv) lead developed cellulitis in the device pocket incision resulting in a 7 day hospital stay post system implant.Subsequently, the patient reported experiencing a high heart rate in the 159 beats per minute (bpm) range and felt like they couldn't move and like they were going to pass out.The patient was seen by the paramedics who noted no anomalies.Additionally, the patient reported experiencing emotional distress related to the system implant and incision scar.Boston scientific technical services (ts) referred the patient to their physician for follow up.No additional adverse patient effects were reported.This product remains implanted and in service.

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

Additional information was received that a subsequent device check was performed and noted no anomalies in relation to the patient's reported high rate.Monitoring will be continued.

• Brand Name: INGEVITY
• 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: 7216345
• MDR Text Key: 98114318
• Report Number: 2124215-2018-01489
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526523458
• UDI-Public: 00802526523458
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/21/2018

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: 11/21/2019
• Device Model Number: 7741
• Other Device ID Number: INGEVITY MRI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/24/2018
• Supplement Dates Manufacturer Received: 01/21/2018
• Supplement Dates FDA Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2017
• 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: 7740; 7741; L331
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 49 YR