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

Model Number	419678
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	05/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient complained of post-operative thumping.It was discovered that the patient was experiencing phrenic nerve stimulation from the left ventricular (lv) lead.The lead was reprogrammed to resolve the stimulation and remains in use.The patient is a participant in the (b)(6) clinical study.No further patient complications have been reported as a result of this event.

• 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: 6923517
• Report Number: 2649622-2017-11501
• Device Sequence Number: 852950
• Product Code: OJX
• UDI-Device Identifier: 00643169601765
• UDI-Public: 00643169601765
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/29/2017

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/17/2019
• Device Model Number: 419678
• Device Catalogue Number: 419678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 10/06/2017
• 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: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 97