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

Model Number	ADDR03
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Codes	Tachycardia (2095); Palpitations (2467)
Date of Event	04/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: unk competitor lead, implanted: (b)(6)1995.Evaluation summary: the device was returned and analyzed.Analysis of the device memory was performed and no anomalies were found.
Event or Problem Description
It was reported that within one day post-av nodal ablation, the patient experienced palpitations and a racing heart rate.During a device check, it was noted that the device was pacing above the lower rate even though the patient was not active.The device was reprogrammed and 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: 6624598
• Report Number: 3004209178-2017-12006
• Device Sequence Number: 10766351
• Product Code: NVZ
• UDI-Device Identifier: 00613994222060
• UDI-Public: 00613994222060
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2017

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?: Yes
• 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: 04/21/2017
• Supplement Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR