MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISENSE LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number	1999/40
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2019
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 the right atrial lead exhibited noise that resulted in episodes of atrial oversensing.The lead was explanted and replaced on (b)(6) 2019.The patient was stable.
Additional Manufacturer Narrative
As received, a partial lead was returned in two pieces.An external insulation abrasion was found at the proximal region of the lead breaching the outer insulation and exposing the outer coil.The cause of the reported event was isolated to the external insulation abrasion which is consistent with friction to the device can.
Additional Manufacturer Narrative
Correction: the previous statement was missing details of length/measurement of the abrasions noted during analysis.Corrected statement below.As received, a partial lead was returned in two pieces.The connector portion measuring 7.2 cm / 7.7 cm (outer insulation / stretched outer coil, inner insulation and inner coil), and the middle portion consisting of the outer insulation and stretched outer coil only, measuring 1.8 cm / 6.0 cm (outer insulation / stretched outer coil).An external insulation abrasion was found at 7.0 ¿ 7.2 cm from the connector pin, breaching the outer insulation and exposing the outer coil consistent with friction to the device can.Unable to determine the actual measurement of the abrasion due to the lead was cut in this region and the other portion of the abrasion was missing.The cause of the reported event was isolated to the external insulation abrasion which is consistent with friction to the device can.No visual anomalies were noted from the middle portion except for damages consistent with procedural damage.

• Brand Name: OPTISENSE LEAD
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9407027
• Report Number: 2017865-2019-17399
• Device Sequence Number: 19390792
• Product Code: NVN
• UDI-Device Identifier: 05414734502467
• UDI-Public: 05414734502467
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2020

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: 02/29/2016
• Device Model Number: 1999/40
• Device Catalogue Number: 1999-40
• Device Lot Number: 3974319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 02/07/2020; 02/13/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 02/11/2020; 02/13/2020
• 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
• Patient Age: 42 YR
• Patient Weight: 73