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

Model Number 0185

Device Problems High impedance (1291); Pocket Stimulation (1463); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Stimulation (1412); Fatigue (1849); Burning Sensation (2146); Complaint, Ill-Defined (2331)

Event Date 12/22/2016

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, only the proximal segment of the lead was returned.The lead was severed 19.6 centimeters (cm) from the is-1 terminal pin.Set screw marks were noted on all terminal connectors in the correct location.Resistance and pressure tests were completed to assess lead electrical performance and insulation integrity of the returned lead segment.Measurements throughout these tests were within normal limits.Laboratory testing of the returned lead segment was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.

Event Description

Boston scientific received information that the patient with this right ventricular (rv) defibrillation lead presented to the emergency room (er) due to heating/warmth sensations in the throat and pocket during pacing.The shock impedance measurements had been trending up, and were subsequently greater than 200 ohms.The patient also had flushing on the left-sided neck area.Their neck was distended, and the patient had pulsations and tremors on the left pectoral, which could not be recreated upon troubleshooting.The patient also reported feeling sluggish.Lead diagnostics were performed and the patient felt every ventricular pace.The rv pacing impedance measurement was 682 ohms and consistent.A surgical revision was performed; the lead was partially abandoned, and a portion of the lead was returned for analysis.A new system was implanted on the patient¿s right side.It was suspected that the patient had subclavian syndrome.Additional information was received which indicated that during the revision, this rv lead was tested via the pacing system analyzer (psa) and still showed high shock impedance measurements.There was no visible injury to the rv lead.The physician chose to replace the lead and utilize the same device.The system was tested during the pre-discharge check and was noted to be fine.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: 6281066
• MDR Text Key: 65864873
• Report Number: 2124215-2017-01398
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• PMA/PMN Number: P910073/S043
• 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: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/27/2009
• Device Model Number: 0185
• Other Device ID Number: ENDOTAK RELIANCE G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2007
• 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: 0185; 4136; D023; T175
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR