MAUDE Adverse Event Report: MPRI CAPSUREFIX NOVUS LEAD MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT

Model Number	5076110
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: ddbb1d1 icd; implanted: (b)(6) 2015, product id 6707-15 x2 adaptors; implanted: (b)(6) 2009.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) longevity was shorter than expected and the battery voltage was rapidly depleting.It was further reported that the atrial lead had exhibited high thresholds for quite a while and the atrial outputs were reprogrammed.The icd and atrial lead remain in use.No patient complications have been reported as a result of this event.
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 atrial pacing capture threshold was elevated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSUREFIX NOVUS LEAD MRI SURESCAN
• Common Device Name: ELECTRODE, PACEMAKER, PERMANENT
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 9496722
• Report Number: 2649622-2019-24138
• Device Sequence Number: 2086520
• Product Code: DTB
• UDI-Device Identifier: 00721902309656
• UDI-Public: 00721902309656
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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: 06/08/2011
• Device Model Number: 5076110
• Device Catalogue Number: 5076110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR