MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA STRAIGHT MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number	439878
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Codes	Edema (1820); Fatigue (1849)
Date of Event	05/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: dtba1qq crt-d, implanted: (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient presented to the clinic with fluid build-up and was found to have bilateral ankle edema with fatigue.The patient admitted to dietary indiscretion.It was noted the left ventricular (lv) lead adapted amplitude had increased due to loss of capture.The lv pacing vector was reprogrammed and the lv lead remains in use.The patient is a participant in the adapt response clinical study.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN PERFORMA STRAIGHT MRI SURESCAN
• Common Device Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8853849
• Report Number: 2649622-2019-13564
• Device Sequence Number: 2731309
• Product Code: OJX
• UDI-Device Identifier: 00643169002487
• UDI-Public: 00643169002487
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2019

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: 07/14/2017
• Device Model Number: 439878
• Device Catalogue Number: 439878
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 08/02/2019
• 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: 6935M62 LEAD, 2088TC LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR