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

Model Number 7741

Device Problems Failure to Capture (1081); Fracture (1260); High impedance (1291); Capturing Problem (2891)

Patient Problems Fall (1848); Perforation of Vessels (2135)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

At this time, the lead remains surgically capped.If the product is explanted and returned, analysis will be performed and this report would be updated at that time.

Event Description

Boston scientific received information that this pacemaker patient has parkinson's disease and was falling at home when her husband caught her under the armpits forcefully.The patient presented to the office not feeling well, and device check found intermittent capture, high thresholds, and out of range high impedances greater than 3000 ohms.An x-ray was performed and confirmed that the right ventricular (rv) lead was fractured.The patient was admitted to the hospital, and was reprogrammed to max outputs until the revision could take place.During the revision, it was determined that the vein was mostly occluded, and a small tear was made in the vessel when several attempts were made to regain access past the occlusion area.The decision was made to abandon the system on the left side due to the occlusion, the patient's parkinson's disease, and advanced age.A new system was implanted on the left side, and the tear was contained with was no adverse patient effects.

• 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: 7983889
• MDR Text Key: 124298067
• Report Number: 2124215-2018-18079
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526523458
• UDI-Public: (01)00802526523458(17)20180720
• Combination Product (y/n): N
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/20/2018
• Device Model Number: 7741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2016
• 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; 7742; L100; L111
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR