MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) TENDRIL STS; PERMANENT PACEMAKER ELECTRODE

Model Number	2088TC/100
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product is registered as a combination product.
Event or Problem Description
It was reported that lead noise was observed on the right ventricular lead via review of remote transmission.The rv lead was explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
Analysis of the lead found external insulation abrasion was noted at 31.4 cm to 31.6 cm from the connector pin breaching the outer insulation and exposing the outer coil, consistent with lead friction to the device can.The exposed outer coil is consistent with the observation from the field of noise.

• Brand Name: TENDRIL STS
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 9965241
• Report Number: 2938836-2020-02685
• Device Sequence Number: 11461654
• Product Code: NVN
• UDI-Device Identifier: 05414734505031
• UDI-Public: 05414734505031
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2020

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: 01/31/2022
• Device Model Number: 2088TC/100
• Device Catalogue Number: 2088TC-100
• Device Lot Number: P000075613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 05/07/2020
• 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 Weight: 75