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

Model Number 0175

Device Problems Over-Sensing (1438); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Ambient Noise Problem (2877); Capturing Problem (2891)

Patient Problems Muscle Stimulation (1412); Patient Problem/Medical Problem (2688)

Event Date 07/01/2016

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested.This report will be updated should further information be received.

Event Description

Boston scientific received information that the patient was struck by lightning and since then this device and right ventricular (rv) lead delivered 11 unneeded shocks to the patient.The pace impedance decreased from 800 to 400 ohms.Additionally, noise oversensing was noted on the rv channel.Boston scientific technical services (ts) was contacted for assistance and recommended device replacement.Additional information received indicates that the device and rv lead caused phrenic nerve stimulation and exhibited high thresholds and low out-of-range pace impedance measurements (<200 ohms).Subsequently, a revision procedure was scheduled.The rv lead was tested with a pacing system analyzer and found to measure low pace impedance measurements.The device was explanted and the rv lead was surgically abandoned.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6023227
• MDR Text Key: 57184877
• Report Number: 2124215-2016-15245
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910073/S041
• 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: 08/25/2016

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: 10/07/2012
• Device Model Number: 0175
• Other Device ID Number: ENDOTAK RELIANCE G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2010
• 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: 0175; 4470; E030
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR