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

Model Number	6935M49
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Over-Sensing (1438); Low impedance (2285)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the right ventricular (rv) lead integrity alert (lia) had triggered due to sensing integrity counter (sic) and a high impedance.It was also noted there was a pacing impedance measurement of 0.A fracture was suspected.The lead was explanted and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the lead was returned for analysis.In addition to returned product analysis, performance data collected from the device was received and analyzed.Analysis of the device memory indicated oversensing associated with the right ventricular lead.Analysis of the device memory indicated the criteria for the 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 oversensing due to non-physiologic signals/sensing integrity counter.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product event summary: the partial lead was returned in segments, analyzed.Analysis indicated that the distal conductor of the lead developed a fracture due to flexing while in vivo.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINT QUATTRO SECURE S
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7634559
• Report Number: 2649622-2018-10441
• Device Sequence Number: 13497295
• Product Code: LWS
• UDI-Device Identifier: 00643169550889
• UDI-Public: 00643169550889
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2018

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: 10/13/2017
• Device Model Number: 6935M49
• Device Catalogue Number: 6935M49
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Received by Manufacturer: 06/02/2018
• Supplement Date Received by Manufacturer: 06/26/2018; 08/20/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 07/02/2018; 08/21/2018
• 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: DVMB1D4 ICD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 9 YR
• Patient Weight: 45