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

Model Number	419378
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of medical devices: 694758 lead implanted (b)(6) 2009; d284trk crt-d implanted (b)(6) 2013.Product event summary: the proximal segment of the lead was returned and analyzed and the distal conductor of the lead became extrinsically fractured due to melting.The setscrew marks on the connector pin were too proximal.The outer insulation of the lead was extrinsically breached due to melting.Visual analysis of the lead indicated apparent explant damage.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the during a device change the top portion of the left ventricular (lv) lead that connects to the device broke.The lv lead was partially removed.The remaining portion of the lv lead was capped and remains in the patient.A new coronary sinus lead was attempted but was unable to be implanted due to patient anatomy.No patient complications have been reported as a result of this event.

• 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: 7415721
• Report Number: 2649622-2018-04024
• Device Sequence Number: 806442
• Product Code: LWP
• UDI-Device Identifier: 00885074200729
• UDI-Public: 00885074200729
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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: Health Professional
• Device Expiration Date: 07/31/2009
• Device Model Number: 419378
• Device Catalogue Number: 419378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 04/10/2018
• 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: 54 YR