MAUDE Adverse Event Report: MPRI ATTAIN ABILITY PLUS MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P

Model Number	429678
Medical Device Problem Codes	Failure to Capture (1081); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Device Overstimulation of Tissue (1991)
Date of Event	04/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5076-45, lead, implanted: (b)(6) 2021.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient experienced extra stimulation from a newly placed right ventricular (rv) lead.The patient stated that when laying down on their left side "it felt like a baby was kicking" and that they had been back to the clinic twice and they no longer feel it.The patient further reports that every night at the same time they feel that same sensation which was attributed to the program that monitors pacing thresholds at different intervals.Additionally, the clinic disclosed that the patient exhibited phrenic stimulation which the patient could not tolerate.Loss of capture was noted several time.The programmed feature that monitors pacing thresholds at different intervals was turned off and outputs were decreased.The rv lead remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN ABILITY PLUS MRI SURESCAN
• Common Device Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 12284945
• Report Number: 2649622-2021-15821
• Device Sequence Number: 3668620
• Product Code: OJX
• UDI-Device Identifier: 00643169860124
• UDI-Public: 00643169860124
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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: 10/04/2021
• Device Model Number: 429678
• Device Catalogue Number: 429678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/05/2021
• 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: W4TR01 CRTP, 459878 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 78