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

Model Number	ADDR06
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	12/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical devices: 455753 lead, implanted (b)(6) 1990.
Event or Problem Description
It was reported that the patient's caregiver sent a remote transmission, and ever since then, the patient's heart rate went to 120-140 beats per minute.In addition, the caregiver stated that they couldn't get the heart rate back down, and suspected that the home monitor caused the rate increase.The patient was sent to the emergency room.No follow-up information could be obtained.The implantable pulse generator (ipg) remains in use.No further patient complications have been reported as a result of this event.
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: 6317764
• Report Number: 3004209178-2017-03162
• Device Sequence Number: 16443990
• Product Code: NVZ
• UDI-Device Identifier: 00613994222077
• UDI-Public: 00613994222077
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2016

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/28/2015
• Device Model Number: ADDR06
• Device Catalogue Number: ADDR06
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: 12/28/2016
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: 5023M58 LEAD
• Outcome Attributed to Adverse Event: Life Threatening