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

Model Number ADDRL1

Device Problem Pacing Problem (1439)

Patient Problems Fainting (1847); No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the leadless implantable pulse generator (ipg) was unable to pace.The device was reprogrammed and remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

It was reported that the implantable pulse generator (ipg) was unable to pace.The device was reprogrammed and remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

It was reported that, post-operatively, the implantable pulse generator (ipg) was unable to pace.The device was re-operated and began to pace.It was reported that, later that night, the patient experienced fainting and the implantable pulse generator (ipg) was explanted and replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that post-operatively, the implantable pulse generator (ipg) was unable to pace.The device was re-operated and began to pace.It was reported that later that night, the patient experienced fainting and the implantable pulse generator (ipg) was explanted and replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• Brand Name: ADAPTA
• 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: 8763664
• MDR Text Key: 150109177
• Report Number: 3008973940-2019-01856
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/26/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2020
• Device Model Number: ADDRL1
• Device Catalogue Number: ADDRL1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 07/05/2019
• Supplement Dates Manufacturer Received: 07/07/2019; 07/15/2019; 07/24/2019; 08/25/2019
• Supplement Dates FDA Received: 07/12/2019; 07/15/2019; 08/15/2019; 08/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2019
• 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