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

Model Number 7742

Device Problems Failure to Capture (1081); Contamination /Decontamination Problem (2895); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem Pleural Effusion (2010)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

This lead was returned to boston scientific¿s post market quality assurance laboratory with the helix mechanism in an extended position.Visual inspection found dried blood/tissue around the helix.Subsequent testing did not identify any product abnormalities that may have caused or contributed to the reported clinical observations.Laboratory analysis was unable to conclusively determine the root cause of the reported helix extension/retraction problems.

Event Description

Boston scientific received information that loss of capture at maximum device outputs and low intrinsic amplitudes were noted on the right ventricular (rv) lead due to dislodgement.Additionally, an echocardiogram showed pericardial fluid.A revision procedure was performed during which time a pericardiocentesis occurred along with attempts to reposition this lead.The helix would no longer extend and retract and the lead was removed from service and replaced.Visual inspection of the helix identified tissue.No additional adverse patient effects were reported.

• 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: 7977385
• MDR Text Key: 124078032
• Report Number: 2124215-2018-15324
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526523489
• UDI-Public: (01)00802526523489(17)20190711
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/11/2019
• Device Model Number: 7742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2017
• 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: 7741; 7742; L311
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 79 YR