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

Model Number 429688

Device Problems Appropriate Term/Code Not Available (3191); High Capture Threshold (3266)

Patient Problems Muscle Stimulation (1412); Syncope (1610); Undesired Nerve Stimulation (1980)

Event Date 04/22/2015

Event Type  Injury  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Concomitant medical products: 6947m55 lead, implanted: (b)(6) 2012.(b)(4).

Event Description

It was reported that the patient feels that stimulation has been worse since the recent device implant.It was noted that the patient has a history of diaphragmatic stimulation since the initial implant of the left ventricular (lv) lead.The physician decided to adjust the left ventricular (lv) lead by reducing the lv output, though the threshold remains high.The patient is enrolled in the wrap-it (world-wide randomized antibiotic envelope infection prevention trial) study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported later that the device had premature battery depletion.It was noted that the device had less than one month estimated longevity from giving the patient appropriate therapy.It was suspected that the high left ventricular (lv) output and thresholds likely caused the premature battery depletion.Additionally, it was further reported that the patient had syncope associated with ventricular tachycardia.It was noted that the patient was walking and had a sudden onset of syncope.There was no warning sign whatsoever.The patient suddenly found themselves on the ground.At the time the patient was unaware of the implantable cardioverter defibrillator (icd) therapy shocks.The symptoms were sudden and rapid in onset.Lasted for less than three minutes.The patient was noted on remote monitoring to have had an episode of ventricular tachycardia, successfully stopped with a single defibrillation.The remote transmission also indicated that the device at that time was near eri (elective replacement indicator) with approximately one month longevity remaining.The device remained in use but plans for replacement of the device during hospital stay were made.The device was explanted and replaced the following day.It was noted that the patient refused a left ventricular (lv) lead revision.The patient is enrolled in the wrap-it (world-wide randomized antibiotic envelope infection prevention trial) study.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.

Manufacturer Narrative

Product event summary: the distal portion of the lead was returned, analyzed, and no anomalies were found.Visual analysis of the lead indicated apparent ex-plant damage.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

It was further reported that there was phrenic nerve stimulation due to the left ventricular (lv) lead.The lv lead was explanted and replaced.No further patient complications have been reported as a result of this event.

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 pacing capture threshold in the left ventricle was high.Information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN ABILITY PLUS
• 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: 5561928
• MDR Text Key: 42331533
• Report Number: 2649622-2016-05159
• Device Sequence Number: 1
• Product Code: OJX
• 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: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/10/2013
• Device Model Number: 429688
• Device Catalogue Number: 429688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2011
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00079 YR
• Patient Weight: 78