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

Model Number 459888

Device Problems High impedance (1291); Capturing Problem (2891); Impedance Problem (2950); High Capture Threshold (3266)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced severe hypotension during hemodialysis treatment which required hospitalization and administration of fluids.Pacing impedance and thresholds were noted to rise around that time with impedance subsequently reaching a high undefined range and thresholds reaching a high range.The lead was reprogrammed with electrical measurements in normal range.The lead remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN PERFORMA S MRI SURESCAN
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11045991
• MDR Text Key: 222646130
• Report Number: 2649622-2020-24999
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601871
• UDI-Public: 00643169601871
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/03/2020
• Device Model Number: 459888
• Device Catalogue Number: 459888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: W4TR03 CRT-P, 5076-45 LEAD, 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR