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

Model Number	419678
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: c4tr01 crtp, implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient experienced diaphragmatic stimulation.It was also reported the patient's right atrial (ra) lead exhibited undersensing, diminished sensing, and high thresholds.It was found the ra lead had dislodged into the superior vena cava (svc), causing the diaphragmatic stimulation.The ra lead was explanted and replaced.It was also reported the patient's right ventricular (rv) lead exhibited undersensing.The rv lead was explanted and replaced.It was also reported the patient's left ventricular (lv) lead exhibited high thresholds.The lv lead remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN ABILITY
• 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: 7670876
• Report Number: 2649622-2018-11067
• Device Sequence Number: 10924035
• Product Code: OJX
• UDI-Device Identifier: 00643169601765
• UDI-Public: 00643169601765
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/18/2019
• Device Model Number: 419678
• Device Catalogue Number: 419678
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR