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

Model Number	1688T/85
Medical Device Problem Codes	Fracture (1260); Capturing Problem (2891)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product is registered as a combination product.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that during a generator upgrade on (b)(6) 2020, when the rv lead thresholds were checked, the thresholds were very poor, and the rv lead was fractured.The right atrial lead was examined, and the lead impedance was very high and was believed that the lead was fractured.The rv lead and atrial lead were explanted and replaced.The lv lead was capped due to dysfunctional.The patient condition was stable.Related manufacturer reference number: 2938836-2020-07019 and 2938836-2020-07020.
Additional Manufacturer Narrative
The reported event of capture problem was confirmed while the reported event of lead fracture was not confirmed.As received a partial lead was returned in two pieces.The connector portion measured 18.5 cm and the middle portion measured 31.5cm / 34.3 cm.External insulation abrasion was noted at 25.1-26.1 cm from the proximal cut end consistent with friction another device or feature of patient¿s anatomy.The reported event of capture problem was isolated to the abrasion found on the lead.Visual and x ray examination did not find any other anomalies with the exception of procedural damage.

• Brand Name: TENDRIL SDX LEAD
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10182263
• Report Number: 2938836-2020-07021
• Device Sequence Number: 19449006
• Product Code: NVN
• UDI-Device Identifier: 05414734005777
• UDI-Public: 05414734005777
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

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: 05/31/2007
• Device Model Number: 1688T/85
• Device Catalogue Number: 1688T-85
• Device Lot Number: 0002186995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: QUICKSITE LV.; TENDRIL SDX LEAD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 106