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

Model Number 8637-20

Device Problems Filling Problem (1233); Improper or Incorrect Procedure or Method (2017); Aspiration Issue (2883); Device Ingredient or Reagent Problem (2910); Infusion or Flow Problem (2964); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Apnea (1720); Bacterial Infection (1735); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Overdose (1988); Pneumonia (2011); Seroma (2069); Swelling (2091); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Dyskinesia (2363); Sedation (2368); Loss of consciousness (2418); Decreased Respiratory Rate (2485); Fluid Discharge (2686); Test Result (2695)

Event Date 06/06/2018

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 (hcp) and a manufacturing representative (rep) regarding a patient receiving 200 0 mcg/ml of lioresal at 950 mcg/day via an implantable pump for intractable spasticity.It was reported the patient was refilled on (b)(6) 2018 and the hcp had a hard time getting the needle in but felt like it went in.The hcp pulled back and there was a ¿tinge of blood¿ but as they continued to pull back it was clear.The hcp got back 10 milliliters (mls) of fluid but expected 6.4 mls.The hcp proceeded with the refill and put 5 mls in and got 5 mls out.No symptoms were noted at the time.It was reported a pocket fill had occurred.Additional information was received from the hcp later that day ((b)(6) 2018).The hcp reviewed that the hcp that did the refill confirmed that they pulled out clear medication, although it was slightly blood tinged.The hcp stated that the hcp confirmed that she was able to withdraw the 5 mls that she put in the reservoir.The hcp stated there had been no swelling, oozing, or anything abnormal to indicate a problem so the patient had left the clinic and went to lunch and later ¿swamped over¿ and became unresponsive.The hcp stated the patient was brought to the emergency room.The hcp stated that she was able to get in the pump and also initially aspirated a tinge of blood, but then it was clear fluid.The hcp stated they withdrew 7 mls, which is what they were expecting.The pocket looked puffy and maybe had some swelling but not completely abnormal.The hcp stated they put the 7 mls back and stuck the patient around the pump to try and see if the she could pull out any fluid, but nothing came out.The hcp stated medication did ooze out of the punctures, but she could not pull anything out.It was reported the patient¿s airway was intubated and the patient was stable.The pump was programmed to minimum rate mode.The patient was being monitored in the intensive care unit (icu).The hcp stated that their normal checks appeared not to work in this case.The hcp was wondering why the fluid they pulled out was clear.The hcp inquired about the possibility of there being an encapsulated cyst in the pocket.The hcp did not understand why they were able to get a clear thin fluid that was flowing well back and forth.The hcp inquired about how long it would take for a patient to experience overdose symptoms and technical services reviewed that would vary by patient and they could not provide a specific time frame.Additional information was provided by the rep.The patient was having a routine pump refill of 20 mls of 2000 mcg/ml lioresal when the event occurred.There were no external patient factors.The rep reported when the refill was performed, the pump said there was 6 mls left in the reservoir.The hcp pulled back 10 mls from what she thought was the pump.It was reported the hcp pushed the new baclofen syringe in and pushed 10 mls in and pulled back 5 mls.The hcp did this until all 20 mls had been injected.It was indicated the patient experienced overdose symptoms which included loss of consciousness and delayed breathing two hours after the refill.The patient¿s family brought the patient to the emergency room at this time.The hcp was able to pull-out the original 6 mls when a different hcp went to the er later to verify the pump reservoir.It was indicated the issue had been resolved at the time of the report.Of note, this is conflicting information because it was also reported the patient was ¿alive-with injury,¿ with a note that the patient was currently intubated in the icu.No further complications were reported.Other medications being given at the time of the event, patient weight, and medical history were unknown.Additional information was received from a healthcare provider via a clinical study reported the patient went for a regular baclofen pump refill, on (b)(6) 2018, and after the refill when the patient's was at a restaurant with their grandparents the patient seemed to have difficulty moving their feet normally.The patient then slumped, seemed sedated, and became unresponsive around 12:15 pm.An ambulance was called and the patient was transported to the emergency department (ed).The patient had respiratory depression bradycardia, and hypotension.The patient had normal oxygen saturation when in the ed.The patient had shallow breaths and became progressively apneic.The patient was intubated.The pump programming was reviewed and the pump was interrogated finding no concerns on interrogation.Seven (7) ml of medication was removed on attempt to access pump.Suspected pocket refill was done earlier in the day.Patient admitted to the hospital.X-rays were performed and there were no osseous findings.Laboratory testing was done on (b)(6)2018 with finding abnormal results.The pump was reprogrammed on (b)(6) 2018.It was indicated the event was related to the device or therapy.The clinical diagnosis was baclofen overdose.The event resulted in in-patient or prolonged hospitalization.The issue was noted as ongoing.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare provider via a clinical study reported the pump was reprogrammed on (b)(6) 2018.It was noted the patient was doing well.The patient had some mild withdrawal symptoms that were treated with valium.The patient was talking and still a little groggy but their personality was intact.

Manufacturer Narrative

Product id 8596sc lot# (b)(4) implanted: (b)(6)2009 explanted: (b)(6)2018 product type catheter if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider via a clinical study reported the cause of the inability to fully aspirate the cap was not determined.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider via a clinical study on (b)(6) 2018.It was reported that the event resolved without sequelae on (b)(6) 2018.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider via a clinical study on 2018-jun-12.It was reported that laboratory testing on (b)(6) 2018 showed (b)(6).

Manufacturer Narrative

Concomitant medical products: product id: 8596sc, serial#: (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2018, product type: catheter, ubd: 2010-07-16, udi: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider via a clinical study on (b)(6) 2018.It was reported that the patient was discharged on (b)(6) 2018, and was readmitted via the ed for baclofen withdrawal on (b)(6) 2018.The catheter access port (cap) was unable to be fully aspirated and fluid was discolored on (b)(6) 2018.The entire system was explanted/replaced on (b)(6) 2018, and electronic analysis of the pump occurred without reprogramming on (b)(6) 2018.The event resulted in prolongation of existing hospitalization.

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial# (b)(4), implanted: (b)(6) 2007, udi: (b)(4), ubd: 2008-11-15, explanted: (b)(6) 2018, product type: catheter.Product id: 8596sc, serial# (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2018, product type: catheter, udi: (b)(4), ubd: 2010-07-16.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider via a clinical study on 2018-jul-11.It was reported that per the site, factors that caused or contributed to the pocket fill included "concern for baclofen pump malfunction." it was further noted that upon surgery for possible catheter revision (on (b)(6) 2018) it was found upon "trembling oump" that the catheter was fractured in multiple pieces.The issue was considered resolved, and the environmental, external, or patient factors that may have led or contributed to the event were unknown.

Manufacturer Narrative

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 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7582321
• MDR Text Key: 110483464
• Report Number: 3004209178-2018-12962
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 09/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1060-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 17 YR