MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) DURATA STS OPTIM PASSIVE FIXATION; DEFIBRILLATION LEAD

Model Number	7171/65
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Date of Event	04/15/2019
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 asymptomatic patient presented to the clinic after receiving vibratory patient notification alert for high, out of range right ventricular pacing lead impedance.In clinic device check showed normal impedance measurements but the session record showed numerous spikes.Lead was capped and replaced on (b)(6) 2019.During the procedure, the patient went bradycardic and hypotensive briefly.Patient was stabilized with medication and increasing the pacing rate on the device.Patient was stable at the end of the procedure.

• Brand Name: DURATA STS OPTIM PASSIVE FIXATION
• Common Device Name: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 8553102
• Report Number: 2938836-2019-03148
• Device Sequence Number: 13553279
• Product Code: LWS
• UDI-Device Identifier: 05414734502443
• UDI-Public: 05414734502443
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/25/2019

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: 06/30/2013
• Device Model Number: 7171/65
• Device Lot Number: 3153181
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 04/25/2019
• 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