MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ADAPTA DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	ADDR03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Unspecified Infection (1930)
Date of Event	03/11/2017
Type of Reportable Event	Death
Event or Problem Description
It was reported by the patient's spouse that the patient had passed away.The spouse reported that after the implantable pulse generator (ipg) was implanted the patient "had an infection." the spouse also mentioned that the patient had many other problems.Follow up with the patient's clinic indicated that they had no records regarding the circumstances of the patient's death.The cause of death was not noted in their records.No further information was able to be obtained.
Event or Problem Description
It was further reported that the patient passed away due to ischemic bowel and the patient's death was unrelated to the device system.There was no known device system infection.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADAPTA DR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 6512708
• Report Number: 3004209178-2017-08825
• Device Sequence Number: 142682
• Product Code: NVZ
• UDI-Device Identifier: 00613994222060
• UDI-Public: 00613994222060
• Combination Product (Y/N): N
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2017

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/28/2017
• Device Model Number: ADDR03
• Device Catalogue Number: ADDR03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: Not provided; 05/15/2017
• Initial Report FDA Received Date: 04/21/2017
• Supplement Report FDA Received Date: 05/16/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMPETITOR LEAD, COMPETITOR LEAD
• Outcome Attributed to Adverse Event: Death
• Patient Age: 83 YR