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

Model Number 7741

Device Problems Failure to Capture (1081); Migration or Expulsion of Device (1395); Capturing Problem (2891); Device Dislodged or Dislocated (2923)

Patient Problems Bradycardia (1751); Dizziness (2194); No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

At this time, the lead remains implanted.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 exhibited high pacing thresholds a few days after the lead was implanted.An x-ray evidenced the lead had migrated.As result, a surgical intervention was performed wherein the lead was successfully repositioned and the patient received intravenous antibiotics.The rv lead remains in service.No additional adverse patient effects were reported.

Event Description

Additional information reported that shortly after the implant, this patient complained of feeling dizziness and his heart rate decreased.At the time, the patient electrogram (egm) showed this rv lead exhibited intermittent loss of capture (loc) and was suspected to be dislodged.All allegations were resolved with the rv lead reposition.

• 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: 7620050
• MDR Text Key: 111694566
• Report Number: 2124215-2018-10231
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/27/2020
• Device Model Number: 7741
• Other Device ID Number: INGEVITY MRI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2018
• 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: 7740; 7741; L331
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR