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

Model Number	VEDR01
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Bradycardia (1751); Fatigue (1849); Lethargy (2560)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
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 was experiencing fatigue, lethargy and bradycardia.The implantable pulse generator (ipg) was found to have migrated to a lateral/axillary position over time and an x-ray indicated there was little or no slack in the right atrial (ra) and right ventricular (rv) leads.It was also noted that the rv lead exhibited no capture, undefined impedance and was suspected to have dislodged.The ra lead was capped and not replaced.The rv lead was capped and replaced.The device was moved to the right side 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: VERSA 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: 7630774
• Report Number: 3004209178-2018-14156
• Device Sequence Number: 19441832
• Product Code: NVZ
• UDI-Device Identifier: 00643169474277
• UDI-Public: 00643169474277
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/08/2018

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: 06/14/2018
• Device Model Number: VEDR01
• Device Catalogue Number: VEDR01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 10/08/2018
• 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: 5076-45 LEAD, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention