MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Headache (1880); Myocardial Infarction (1969); Tachycardia (2095); Tingling (2171); Dizziness (2194); Numbness (2415)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Fast heart beat such that she thought she was having a heart attack [heart attack] ([heart rate increased]), felt tired [tiredness], numbness and tingling in arm [numbness of upper arm], numbness and tingling in arm [tingling of extremity], headache [headache], dizziness [dizziness], received injection in shoulder (off label use) [off label use].Case narrative: initial information from united states received on 07-aug-2020 regarding an unsolicited valid serious case received from the patient.This case involves adult female patient who reported fast heart beat such that she though she was having a heart attack, had headache, dizziness, felt tired, numbness and tingling in arm (paresthesia and hypoesthesia) and received injection in shoulder (off label use), with use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient was sensitive to many drugs.On an unknown date in (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate (formulation: solution for injection) at a dose of 6 ml once via unknown route (lot - unknown) for unknown indication in her shoulder (off label use).Information regarding batch number was requested.On an unknown date in 2020 after a latency of few days had a headache, dizziness, felt tired, numbness and tingling in her arm and a fast heartbeat such that she thought she was having a heart attack (seriousness criteria: medically significant).Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment.The patient outcome is reported as not applicable for received injection in shoulder (off label use); recovered for rest of the events.A product technical event was initiated and the results for the same were pending.

Event Description

Fast heart beat such that she thought she was having a heart attack [heart rate increased].Felt tired [tiredness], numbness and tingling in arm [numbness of upper arm], numbness and tingling in arm [tingling of extremity], headache [headache], dizziness [dizziness] , received injection in shoulder (off label use) [off label use].Case narrative: upon internal review on (b)(6) 2020 the case initially processed as serious case was re-assessed as non-serious case as the serious event of fast heart beat such that she thought she was having a heart attack (pt: myocardial infarction) was deleted.Initial information from united states received on (b)(6) 2020 regarding an unsolicited valid non-serious case received from the patient.This case involves adult female patient who reported fast heart beat such that she thought she was having a heart attack, had headache, dizziness, felt tired, numbness and tingling in arm (paresthesia and hypoesthesia) and received injection in shoulder (off label use), with use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient was sensitive to many drugs.On an unknown date in (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate (formulation: solution for injection) at a dose of 6 ml once via unknown route (lot - unknown) for unknown indication in her shoulder (off label use).Information regarding batch number was requested.On an unknown date in 2020 after a latency of few days had a headache, dizziness, felt tired, numbness and tingling in her arm and a fast heartbeat such that she thought she was having a heart attack (seriousness criteria: medically significant).Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment.The patient outcome is reported as not applicable for received injection in shoulder (off label use); recovered for rest of the events a product technical complaint (ptc) was initiated and the results for the same were pending with global ptc number (b)(4).Follow up information was received on (b)(6) 2020 from other healthcare professional.Global ptc number added.No significant information was received.Upon internal review on (b)(6) 2020 the event of fast heart beat such that she thought she was having a heart attack (pt: myocardial infarction) was deleted from the case.Clinical course was updated, and text amended.Local comments: downgrade.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 10384094
• MDR Text Key: 209595368
• Report Number: 2246315-2020-00090
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention