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

Model Number 8637-40

Device Problems Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954)

Patient Problems Fever (1858); Low Blood Pressure/ Hypotension (1914); Liver Damage/Dysfunction (1954); Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Irritability (2421); Constipation (3274)

Event Date 06/05/2020

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 healthcare provider regarding a patient receiving lioresal via an implanted infusion pump.It was reported on (b)(6) 2020, the patient presented to the emergency room with increased agitation and muscle tightness.Initially, they assumed this was due to constipation and other abdominal issues.The patient was treated symptomatically with oral baclofen and benzodiazepines.Over the next week, the patient underwent what caller described was a "waxing and waning picture" with some clinical improvement on certain days.Then the patient would worsen again.It was unknown whether the patient was an inpatient during this time.Caller stated that they tried to have the family come back to the hospital several times and considered having the pump "re-cathed." the family was concerned about covid and caller reported hearing from the family 10 days after the initial emergency room visit.The patient had been sent to an unknown outside hospital with high grade fever.The patient decompensated into acute liver failure.The patient was hypotensive and required fluid resuscitation.Caller further described this as a "hypotensive crisis" and that the patient had myocardial dysfunction and was experiencing severe withdrawal symptoms.The patient was transferred to caller's facility and admitted on (b)(6) 2020, where the patient remains an inpatient.On (b)(6) 2020, the patient tested positive for covid antibodies.The patient had previously been tested for covid several times and was negative.Last thursday, ((b)(6) 2020) the patient had another episode of sudden hypotension.As of yesterday, the patient was still requiring dopamine to support their blood pressure (but the patient's blood pressure was doing better).The patient's cardiac function appeared to be improved.Last friday ((b)(6) 2020), while assessing the patient they found out the patient had no baclofen in their pump.Either the pump had mechanical issues or there was a leak with the catheter.Note: clarified that they have not confirmed there is a mechanical issue or leak with the catheter.This assumption was made because of the huge discrepancy they found in the volume of the pump.The hcp was assuming the patient had been in baclofen withdrawal since their initial presentation.It took the patient 10 days to acutely decompensate.They would have expected the acute withdrawal to have occurred more immediately.On friday ((b)(6) 2020), the lioresal pump was refilled.The patient was restarted at 400 mcg daily.The patient is doing much better.It does seem to be working to some degree as the patient is showing signs that he is receiving intrathecal baclofen.They are gradually titrating up the dose; the patient is on500 mcg daily and they intend to keep titrating up to his original dose (844 mcg daily).Caller anticipates that the patient will make a relatively good recovery, assuming that all symptoms are due to some issue with the baclofen pump.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare provider who reported that the cause for the withdrawal symptoms was determined, the pump ran empty, unknown why.The actions and interventions taken to resolve the baclofen withdrawal symptoms were a refill was performed on june 20 which seemed to resolve the issue.A catheter dye study and ct was performed as well which determined no issues with the catheter.Per the healthcare provider, the baclofen withdrawal symptoms event had been resolved.The patient was about 90% back to baseline.No further complications were reported or anticipated regarding the event.

Manufacturer Narrative

Corrected information: follow up # 001 should have included the following: the initial mdr was filed as mfr report # (b)(4).Additional review indicated the correct manufacturing site is (b)(4).If information is provided in the future, a supplemental report will be issued.

• 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 MN 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10201586
• MDR Text Key: 201200698
• Report Number: 2182207-2020-00426
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2020
• Date Device Manufactured: 07/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 29