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

Model Number	ADSR01
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient had a heart rate lower than the programmed lower rate of the implantable pulse generator (ipg).The ipg remains in use.No patient complications have been reported as a result of this event.

• Brand Name: ADAPTA
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SG 486056
• MDR Report Key: 8928726
• Report Number: 3008973940-2019-02341
• Device Sequence Number: 11274676
• Product Code: NVZ
• UDI-Device Identifier: 00643169709041
• UDI-Public: 00643169709041
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/28/2019
• Device Model Number: ADSR01
• Device Catalogue Number: ADSR01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR