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

Model Number	ADVDD01
Medical Device Problem Code	Under-Sensing (1661)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2017
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 an electrocardiogram suggested that the patient was in atrial fibrillation (af); however, the device atrial electrogram showed no discernable af signals suggesting undersensing of the implantable pulse generator (ipg) and vdd lead system.The ipg and lead remain in use.No patient complications have been reported as a result of this event.

• Brand Name: ADAPTA VDD
• 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: 7093720
• Report Number: 3004209178-2017-25409
• Device Sequence Number: 1379161
• Product Code: NVZ
• UDI-Device Identifier: 00613994222107
• UDI-Public: 00613994222107
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2017

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: 11/28/2015
• Device Model Number: ADVDD01
• Device Catalogue Number: ADVDD01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2017
• Initial Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR