MAUDE Adverse Event Report: GUIDANT CRM CARIBE INGEVITY; IMPLANTABLE LEAD

Model Number 7741

Device Problem Defective Device (2588)

Patient Problem Myocardial Infarction (1969)

Event Date 07/11/2018

Event Type  Death  

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

Boston scientific received information that during a pacemaker system implant, the right ventricular (rv) lead was implanted without issue.The numbers were measured and had normal function.The physician experienced difficulty implanting the right atrial (ra) lead.No sensing or threshold could be obtained and high out of range impedances were present, once the ra lead was placed.When the lead was connected to the pacemaker, noise and the high pacing impedances were still present.A new pacemaker was used and the issue remained.The system was implanted.The following day, there was still noise and no diagnostics on the ra channel.Less than 2 weeks later, the patient presented to the emergency room with a myocardial infarction.It was determined by an electrophysiologist, that the ra and rv leads were implanted into the arterial system of the heart.The ra lead was in the "rca" and the rv lead was in the left ventricle.The physician attempted to put in a balloon pump due to the non-functioning rv chamber.The device system remains implanted and the patient was going to be transferred to another facility.No additional adverse patient effects were reported.No further information is known at this time.

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 in mid-(b)(6) 2018 from the patient's spouse that the cause of death was due to the pacemaker.According to the boston scientific's technical service consultant, the device and leads were not explanted post-mortem and will not be available for return.

• Brand Name: INGEVITY
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): GUIDANT CRM CARIBE; dorado PR 00646
• Manufacturer (Section G): GUIDANT CRM CARIBE; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515826168
• MDR Report Key: 7918871
• MDR Text Key: 122044956
• Report Number: 2124215-2018-18445
• Device Sequence Number: 1
• Product Code: LWP
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/11/2020
• Device Model Number: 7741
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 09/17/2018
• Supplement Dates FDA Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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: 4469; 7731; 7735; 7740; 7741; L331
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR