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

Model Number	ADDR01
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
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 thinks their implantable pulse generator (ipg) is not "working well".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; SN 486056
• Manufacturer (Section G): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SN 486056
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13655986
• Report Number: 3008973940-2022-00924
• Device Sequence Number: 16720440
• Product Code: NVZ
• UDI-Device Identifier: 00643169708600
• UDI-Public: 00643169708600
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2022

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: ADDR01
• Device Catalogue Number: ADDR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 03/02/2022
• Date Device Manufactured: 10/10/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4024-58 LEAD, 5068-45 LEAD
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 95 KG