MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	694775
Medical Device Problem Codes	Failure to Capture (1081); Fracture (1260); High impedance (1291); Over-Sensing (1438); High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter.Analysis of the device memory indicated oversensing associated with the right ventricular lead.Analysis of the device memory indicated the criteria for right ventricular lead integrity alert were met.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was beyond the expected upper range.Analysis of the device memory indicated an alert for lead impedance out of range.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that right ventricular (rv) lead exhibited high thresholds, loss of capture, high and undefined pacing impedances and oversensing.A possible lead fracture was suspected.It was noted that a lead integrity alert was triggered, a rv bipolar lead impedance alert was triggered, and that there was a sensing issue due to number of short v-v intervals.The rv lead was capped and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that this capped right ventricular (rv) lead had been partially explanted.
Additional Manufacturer Narrative
Product event summary: the proximal portion of the lead was returned, analyzed.Analysis indicated the distal conductor of the lead developed a fracture due to flexing while in vivo.The interior superior vena cava defibrillation cable developed a fracture at the first rib/clavicle location while in vivo.The proximal conductor of the lead developed a fracture due to flexing while in vivo.The right ventricular defibrillation coil was fractured at the 1st rib/clavicle location.The inner insulation of the lead developed a breach at the first rib/clavicle location while in vivo.The outer insulation of the lead developed a breach at the first rib/clavicle location while in vivo.The outer insulation of the lead was breached due to bi/multi-lumen tubing voids while in vivo.The overlay tubing was breached at the 1st rib/clavicle location.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINT QUATTRO SECURE
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7414541
• Report Number: 2649622-2018-03535
• Device Sequence Number: 1446461
• Product Code: LWS
• UDI-Device Identifier: 00613994740939
• UDI-Public: 00613994740939
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2020

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: Lay User/Patient
• Device Expiration Date: 07/12/2013
• Device Model Number: 694775
• Device Catalogue Number: 694775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 12/17/2019; 01/02/2020
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 12/20/2019; 01/06/2020
• 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: D284VRC ICD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 111