MAUDE Adverse Event Report: MPRI ATTAIN OTW; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Model Number	419378
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: c4tr01 ipg, implanted: (b)(6) 2014.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that both the left ventricular lead and the atrial lead had high thresholds.Both leads were 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 in segments, analyzed, and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN OTW
• Common Device Name: PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8540161
• Report Number: 2649622-2019-06825
• Device Sequence Number: 2431106
• Product Code: LWP
• UDI-Device Identifier: 00885074200729
• UDI-Public: 00885074200729
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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: 10/24/2009
• Device Model Number: 419378
• Device Catalogue Number: 419378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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: 506852 LEAD, 5568-45 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR