MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS SENSIA IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number SEDR01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Heart Failure (2206)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

In response to the advisory describing the potential for device circuit error to occur while the device is processing an atrial-sensed event, the implantable pulse generator (ipg) was prophylactically reprogrammed.It was noted that the patient experienced worsening heart failure related to the non-optimal pacing mode.No device malfunction was observed while the device was in use, however, the device was functioning in a mode susceptible to circuit error and was therefore reprogrammed to preclude harm to the patient.The device software was later updated, and the device was reprogrammed back to an optimal pacing mode.No further patient complicationshave been reported as a result of this event.

• Brand Name: SENSIA IPG
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9306967
• MDR Text Key: 166140625
• Report Number: 3008973940-2019-03033
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/11/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Model Number: SEDR01
• Device Catalogue Number: SEDR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/11/2019
• Date Device Manufactured: 09/13/2017
• 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): Required Intervention
• Patient Age: 25 YR