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

Model Number 0185

Device Problems Fracture (1260); Pacing Problem (1439); Pocket Stimulation (1463); Ambient Noise Problem (2877); Material Integrity Problem (2978)

Patient Problems Muscle Stimulation (1412); Abdominal Pain (1685)

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Event Description

Boston scientific received information that this patient came into the hospital due to pain/twitching in the stomach.During the follow up many ventricular fibrillation/ventricular tachycardia episodes were seen which weren't true arrhythmias but rather noise resulting in inappropriate anti tachycardia therapy to be delivered.Provocation tests were performed and noise was reproduced.An x-ray was performed which did not reveal a perforation.A revision took place and upon extracting this right ventricular (rv) lead insulation damage as well as a lead fracture was seen.The lead will be returned.No adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory the complete lead was returned.Visual inspection noted that the trilumen insulation was abraded though the rs- lumen approximately 357 to 373 mm from the terminal pin.There was noted webbing damage between the conductors in the area as well.Microscopic analysis indicated that the damage was initiated by localized compressive stress on the tubing surface.Due to the location and the type of damage it is likely this was caused by entrapment in the clavicle/first rib region.

• 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: 5371156
• MDR Text Key: 36116553
• Report Number: 2124215-2015-16877
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• 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: 01/12/2016

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: 01/27/2014
• Device Model Number: 0185
• Other Device ID Number: ENDOTAK RELIANCE G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 01/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2012
• 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: 78 YR