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

Model Number	693558
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's right ventricular (rv) lead exhibited high and rising impedance.The rv lead was capped.During replacement of the rv lead, the helix of the replacement lead would not deploy properly.A different replacement lead was chosen and implanted.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the full lead was returned, analyzed, and the helix of the lead was extrinsically bent.The distal lv (low voltage) electrode of the lead was covered in body tissue/fibrotic growth.The helix of the lead had an out of specification analysis result for extension/retraction due to greater than indicated number of turns to extend.Visual summary analysis of the lead indicated damage at implant.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.
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: 6468943
• Report Number: 2649622-2017-03720
• Device Sequence Number: 16262426
• Product Code: LWS
• UDI-Device Identifier: 00643169535909
• UDI-Public: 00643169535909
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2017

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: 06/29/2018
• Device Model Number: 693558
• Device Catalogue Number: 693558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: Not provided; 04/17/2017
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 06/08/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR