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

Model Number	439678
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was symptomatic and was seen in the clinic.Interrogation of the device found anodal stimulation.Programming changes were made and the left ventricular lead remains in use.The patient is a participant in the product surveillance registry.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN ABILITY STRAIGHT
• 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: 6783330
• Report Number: 2649622-2017-09728
• Device Sequence Number: 1039504
• Product Code: OJX
• UDI-Device Identifier: 00643169601802
• UDI-Public: 00643169601802
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/02/2017

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/10/2018
• Device Model Number: 439678
• Device Catalogue Number: 439678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2017
• Initial Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5076-45 LEAD, 5076-52 LEAD, C6TR01 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Weight: 90