MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE

Model Number 0295

Device Problems Failure to Capture (1081); Pocket Stimulation (1463); Capturing Problem (2891); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem Muscle Stimulation (1412)

Event Date 10/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.The rv lead passed electrical testing.It was found that the helix mechanism failed to operate, most likely due to dried body fluid/blood in the mechanism.No damages were noted at the lead tip or helix that would have contributed to the dislodgement.

Event Description

Boston scientific received information that this patient experienced diaphragmatic stimulation and their right ventricular (rv) lead exhibited loss of capture.No asystole was observed.The lead had normal sensing and impedance measurements were within normal range.A revision procedure was performed due to concern of exit block.While repositioning the lead, the physician attempted to retract the helix however was unsuccessful and the lead dislodged.The physician then elected to fully extract the lead.Once removed, the physician again unsuccessfully attempted to retract the helix.The lead was returned for analysis and another rv lead was implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

--.

Event Description

Boston scientific received information that this patient experienced diaphragmatic stimulation and their right ventricular (rv) lead exhibited high pacing threshold measurements and loss of capture.The patient never required rv pacing, and no asystole was observed.The lead had normal sensing and impedance measurements were within normal range.A micro-dislodgement was suspected but not confirmed.A revision procedure was performed due to concern of exit block.While repositioning the lead, the physician attempted to retract the helix however was unsuccessful and the lead dislodged.The physician then elected to fully extract the lead.Once removed, the physician again unsuccessfully attempted to retract the helix.The lead was returned for analysis and another rv lead was implanted.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5420524
• MDR Text Key: 37836504
• Report Number: 2124215-2016-02503
• Device Sequence Number: 1
• Product Code: NVY
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/17/2015
• Device Model Number: 0295
• Other Device ID Number: RELIANCE 4-SITE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/30/2015
• Initial Date FDA Received: 02/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2013
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR