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

Model Number	6946M55
Medical Device Problem Codes	High impedance (1291); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the full lead was returned, analyzed, and no anomalies were found.
Event or Problem Description
It was reported that during an initial implant procedure, a right ventricular (rv) lead was positioned, tested, and secured to the i mplantable cardioverter defibrillator (icd).Testing through the device revealed high pacing impedance.The lead was removed from the connector block, repositioned, and would not go through the connector block.The device set screw was backed out and reattempted but the lead would still not go through the connector block.The icd was removed and a new device was connected with the same results, so the physician decided to implant a new rv lead.The new lead went through the connector block with no issues and was ultimately positioned, tested, and implanted without incidence.It was felt that there was a connector pin issue with the original lead.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.

• Brand Name: SPRINT QUATTRO
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6320114
• Report Number: 2649622-2017-01382
• Device Sequence Number: 830284
• Product Code: LWS
• UDI-Device Identifier: 00643169335561
• UDI-Public: 00643169335561
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2018
• Device Model Number: 6946M55
• Device Catalogue Number: 6946M55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Initial Date Received by Manufacturer: 11/11/2016
• Supplement Date Received by Manufacturer: 11/11/2016
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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: DDMB1D4 ICD, DDMB1D4 ICD
• Patient Age: 60 YR