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

Model Number 429888

Device Problems Failure to Capture (1081); High impedance (1291); Capturing Problem (2891); Adverse Event Without Identified Device or Use Problem (2993); High Capture Threshold (3266)

Patient Problems Muscle Stimulation (1412); Congestive Heart Failure (1783); No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 694958 lead, implanted: (b)(6) 2006.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 the impedance of the left ventricular pacing lead was beyond the expected upper range.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the left ventricular (lv) lead exhibited high impedance and no capture.The lead was reprogrammed and remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

It was reported that the left ventricular (lv) lead exhibited undefined/high impedance and no capture.The lead was reprogrammed and remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information received indicated the patient was hospitalized due to congestive heart failure symptoms.It was further reported a lead integrity alert triggered and the patient was later brought into the clinic where loss of bi-ventricular pacing was identified.Additional reprogramming was performed changing the pacing vector and lowering the impedance alert parameters.Bi-ventricular pacing was restored.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information reported the patient was seen again for acute onset of congestive heart failure and the lv lead exhibited rising and high thresholds, and diaphragmatic stimulation.The lead was subsequently programmed off and remains in the patient.

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 the impedance of the left ventricular pacing lead was beyond the expected upper range.Analysis of the device memory indicated pacing capture threshold in the left ventricle was high.Analysis of the device memory indicated pacing capture threshold issue in the left ventricle.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN PERFORMA
• 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: 8461900
• MDR Text Key: 140224399
• Report Number: 2649622-2019-05212
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601833
• UDI-Public: 00643169601833
• Combination Product (y/n): N
• 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,Followup,Followup,Followup,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/27/2018
• Device Model Number: 429888
• Device Catalogue Number: 429888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DTBA1Q1 CRTD, 5076-45 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR