MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)

Patient Problems Stroke/CVA (1770); Headache (1880); Muscle Weakness (1967); Muscular Rigidity (1968); Pain (1994); Loss of Vision (2139); Coma (2417); Loss of consciousness (2418); Confusion/ Disorientation (2553); Convulsion/Seizure (4406); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/21/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal lioresal 2000 mcg/ml at 200 mcg/day via an implantable pump.It was reported that the patient went to the hospital for a refill.The expected reservoir volume (erv) was 4 ml, and the actual reservoir volume (arv) was 0 ml.The hcp suspected ¿bad dosing¿.It was noted that patient had been receiving a dose of 200 mcg/day for 15 years.They put 10ml in the pump and administered a bolus of 50 mcg.After 8 hours, they administered another 50 mcg, and the patient was hospitalized.The patient began to have problems, and the patient was now at the intensive care unit (icu).It looked like a stroke, and they did mri.It confirmed ¿some ongoing incident¿, but they did not know if it was related to the pump.Surgical intervention did not occur.It was unknown if surgical intervention was planned.The issue was not resolved.The patient's status was alive - no injury.It was unknown if any environmental, external or patient factors might have led or contributed to the event.The manufacturer representative looked up the serial number of the pump, and it was not affected by a field action.The pump was implanted in (b)(6) 2018 (no further specific date provided).In formation regarding the patient¿s medical history and other medications was unavailable.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a foreign healthcare professional (hcp) via a manufacturer representative.It was reported that the hcp was unable to clarify the meaning of ¿bad dosing¿.At the time of the refill, the patient was experiencing increased spasticity, pain, and pressure in the head.The 50 mcg bolus was administered to provide relief due to the patient¿s empty pump and spasticity.The 50 mcg bolus [initially] resulted in an outcome of the patient ¿feeling better¿.The patient did not experience any symptoms at the beginning [after the bolus].About 5 hours later, the patient experienced slight disorientation and ¿a decrease in desired spasticity¿.It was noted that ¿it looked like more than 50 mcg had been delivered¿.The patient¿s problems that resulted the patient being in the icu included loss of consciousness, coma, epi attack, loss of vision, and signs of a stroke.After the bolus administration, the symptoms of a vascular event started; it was ¿probably [a] vasospasm¿.It was noted that the previously mentioned ¿ongoing incident¿ was ¿probably [a] vasospasm¿.A stroke was confirmed via ct, mr, and mrag.Surgical intervention was not planned.The issue was not resolved.The hcp was contacted again to clarify if there was evidence of a use error, and the hcp¿s response indicated that ¿after the second bolus administration, the symptoms of a vascular event started, probably vasospasm and loss of consciousness which ended in coma.After 100 mcg it should not happen¿¿; that was why the hcp thought there was a significant overdose.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11753647
• MDR Text Key: 248225459
• Report Number: 3004209178-2021-07009
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 04/30/2021
• Supplement Dates Manufacturer Received: 04/30/2021; 05/03/2021
• Supplement Dates FDA Received: 04/30/2021; 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 36 YR
• Patient Weight: 70