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

Model Number 7741

Device Problems Difficult To Position (1467); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2017

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection noted the helix was retracted.Resistance testing found the lead was not electrically continuous.Detailed analysis confirmed that the inner conductor coil had a break at the distal end of the terminal pin.Based upon the clinical observations and the laboratory findings, we believe that torsional overstress during attempts to extend/retract the helix caused the inner conductor coil to break.

Event Description

Boston scientific received information that during the implant procedure, following successful lead placement and fixation, this lead dislodged.The physician elected to retract the helix and secure the lead tip a second time; however, the helix was no longer functional.The lead was removed and replaced in absence of any adverse patient effects.The product was later returned for analysis.

• 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: 6703369
• MDR Text Key: 79758013
• Report Number: 2124215-2017-08717
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/10/2019
• Device Model Number: 7741
• Other Device ID Number: INGEVITY MRI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2017
• 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
• Patient Age: 87 YR
• Patient Weight: 52