MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS ADAPTA DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number ADDRL1

Device Problem Pacing Problem (1439)

Patient Problems Syncope (1610); Cardiopulmonary Arrest (1765); Death (1802)

Event Date 12/16/2017

Event Type  Death  

Manufacturer Narrative

Concomitant product(s): product id: 5054-58 lead, implanted: (b)(6) 2004.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced syncope and was transported to the hospital.The implantable pulse generator (ipg) failed to pace and right ventricular (rv) increased and high thresholds.The device was interrogated and pacing was resumed after increasing the rv lead output.Shortly after, the patient experienced respiratory arrest and despite resuscitation efforts, the patient died.

• Brand Name: ADAPTA DR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SG 486056
• Manufacturer (Section G): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SG 486056
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7153409
• MDR Text Key: 96001272
• Report Number: 3008973940-2017-01657
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2017

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/14/2013
• Device Model Number: ADDRL1
• Device Catalogue Number: ADDRL1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2017
• Initial Date FDA Received: 12/28/2017
• Date Device Manufactured: 02/16/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR