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

Model Number	693558
Medical Device Problem Codes	Bent (1059); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the attempted implant of this right ventricular (rv) lead, after multiple extensions and retractions of the helix because of poor sensing, the lead was removed from the body and examined.The physician noted that the tip was askew and the helix was plugged with tissue.The lead was not used and a different lead was implanted.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the full lead was returned and analyzed.Analysis indicated that the helix of the lead was extrinsically bent.Visual analysis of the lead indicated damage at implant.The analysis noted that the lead was returned with the helix bent.There was dried blood but no tissue visible on helix.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 6626683
• Report Number: 2649622-2017-06351
• Device Sequence Number: 13637960
• Product Code: LWS
• UDI-Device Identifier: 00643169535909
• UDI-Public: 00643169535909
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2017

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: 09/30/2018
• Device Model Number: 693558
• Device Catalogue Number: 693558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 06/29/2017; 06/29/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 08/09/2017; 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR