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

Model Number	429678
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the right ventricular (rv) and left ventricular (lv) leads dislodged.Both were to be repositioned, however the rv lead helix could not be retracted and upon removing the lead from the patient, there was tissue in the lead tip.The lv lead was dropped from the sterile field.The lead were not re-used and new leads were implanted.When the physician connected the new rv lead to the chronic device, the high voltage impedance measured high.It was re-inserted into the device header with the same result and when the lead tested within normal limits through the lead analyzer, the physician requested a new device.The chronic device was explanted and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary : the full lead was returned, analyzed, and no anomalies were found.The setscrew marks on the connector pin were too proximal.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN ABILITY PLUS
• 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: 7462746
• Report Number: 2649622-2018-07067
• Device Sequence Number: 1094788
• Product Code: OJX
• UDI-Device Identifier: 00643169860124
• UDI-Public: 00643169860124
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2018

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: 03/01/2019
• Device Model Number: 429678
• Device Catalogue Number: 429678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 05/08/2018
• 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: 76 YR