MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISURE PASSIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number	LDP220Q/65
Medical Device Problem Codes	High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that a patient presented remotely with a right ventricular lead with both defibrillation and pacing impedance high and out of range.Programming changes were made to address this issue.The patient was stable.
Additional Manufacturer Narrative
Additional: b5, h6.
Event or Problem Description
New information notes that while monitoring this lead, the values for pacing impedance, defibrillation impedance, and capture threshold had constantly risen.Lead extraction had been discussed but not scheduled as of yet.
Event or Problem Description
New information notes that the lead was extracted and replaced.Calcification was noted on the tip of the lead.The patient was stable.
Additional Manufacturer Narrative
Additional: b1, b2, b5, d7.H1, h6.
Additional Manufacturer Narrative
Additional: d10.The reported events of high pacing lead impedance, high defibrillation impedance, high pacing threshold and ¿appears to be calcification at the tip of the lead¿ were confirmed.As received, a partial lead was returned in two pieces.Visual inspection of the partial lead found calcification covering the ring electrode and right ventricular shock coil which is assumed to be the cause of the rise in the pacing/hv impedance and capture threshold as indicated by the remote care records.Lead impedance test could not be performed due to as received procedural damage to the lead.

• Brand Name: OPTISURE PASSIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8584537
• Report Number: 2017865-2019-06550
• Device Sequence Number: 296335
• Product Code: NVY
• UDI-Device Identifier: 05414734507455
• UDI-Public: 05414734507455
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/12/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: LDP220Q/65
• Device Catalogue Number: LDP220Q-65
• Device Lot Number: 4759416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 06/18/2020; 09/15/2020; 10/27/2020
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 07/06/2020; 09/17/2020; 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention