MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION POSTERIOR ANNULOPLASTY BAND; RING, ANNULOPLASTY

Model Number	H607M63
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Anemia (1706); Atrial Fibrillation (1729); Bradycardia (1751); Congestive Heart Failure (1783); Non specific EKG/ECG Changes (1817); Fainting (1847)
Date of Event	08/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the band remains implanted.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information from an email sent by the patient to medtronic's technical services that following the annuloplasty band implant the electrocardiogram (ecg) has shown persistent atrial fibrillation (afib) and severe bradycardia.The patient reported heart failure symptoms and mild anemia.Despite this, the patient cycles 250 to 300 miles per week and reported this vigorous aerobic exercise resets the rhythm to a junctional rhythm at 60 bpm for a few hours.Holter monitor has shown a nighttime low of 30 bpm and dropped beats.The patient reported fainting twice.No additional adverse patient effects were reported. .

• Brand Name: POSTERIOR ANNULOPLASTY BAND
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9848356
• Report Number: 2025587-2020-00826
• Device Sequence Number: 2887037
• Product Code: KRH
• UDI-Device Identifier: 00613994759177
• UDI-Public: 00613994759177
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K960356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2020

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: Health Professional
• Device Expiration Date: 01/09/2022
• Device Model Number: H607M63
• Device Catalogue Number: H607M63
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/18/2020
• 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: Life Threatening
• Patient Age: 68 YR