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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Insufficient Information (3190)
Patient Problems Dyspnea (1816); Fatigue (1849); Muscle Spasm(s) (1966); Muscular Rigidity (1968); Neurological Deficit/Dysfunction (1982); Seizures (2063); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Irritability (2421); Cognitive Changes (2551); Confusion/ Disorientation (2553); Constipation (3274)
Event Date 09/10/2018
Event Type  Injury  
Manufacturer Narrative
Event date is approximate. The main component of the system. Other relevant device(s) are: product id: 8781, (b)(4), implanted: (b)(6) 2018, product type: catheter, ubd: 08-sep-2018, (b)(4) and product id: neu_unknown_prog, lot/serial# unknown, implanted: n/a, explanted: n/a, product type: programmer, physician; ubd: n/a. Udi#: n/a. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a manufacturing representative (rep), and also a consumer, regarding a patient receiving 2000 mg/ml of baclofen at 500 mcg/day via an implantable pump for intractable spasticity. It was reported the patient had experienced an increase in seizures, an increase in spasticity, and was feeling sleepy. It was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue. A dye study was performed (b)(6) 2018 without anyone from the manufacturer present. The doctor aspirated clear fluid from the catheter access port (cap) but could not shoot dye. It was reported the radiologist did not program the patient¿s pump to prime the catheter again after the dye could not be injected. It was indicated that no one at the dye study knew to prime the catheter. The rep reported later the patient had a ¿rapid response¿ called in with the hospital. The patient was having trouble breathing and was intubated. On 2018-sep-11 the rep received information from a healthcare provider that the patient was ¿doing better. ¿ the rep was not aware of any interventions/actions taken to resolve the issue. The issue had not been resolved at the time of the report. Other medications being taken at the time of the event, patient weight, and medical history were unknown. The patient¿s status at the time of the event was provided as alive - no injury. Information was also received from the consumer regarding the patient on 2018-sep-11. The consumer reported the patient¿s pump had malfunctioned. The consumer stated the patient had a magnetic resonance imaging procedure (mri) and they were told that the patient was not supposed to. The consumer reported it caused "neurological symptoms" and "burning" in the patient¿s legs. It was also reported the patient had not had a bowel movement ¿in so many days. ¿ the consumer reported the patient was also ¿having jerks,¿ ¿not responding,¿ and not asking questions appropriately. Later in the call, the consumer stated the patient just regained their sense back. It was reported the pump showed it had been ¿locked¿ and was not working properly. It was indicated the device had been checked the day before on (b)(6) 2018 and it showed a malfunction. The patient was having breathing difficulties. It was reported one nurse did notice an alarm. It was reported while the patient was in the hospital they gave him 5 mg of baclofen then 15 mg. It was indicated the pump had helped the patient at first. The consumer was redirected to follow-up with their healthcare provider. The consumer stated they wanted to replace the pump and wanted to know if it was safe to replace the pump. It was initially stated the symptoms began a week earlier (relative to the day of the report, 2018-sep-11) then the consumer stated it had been over a week. No further complications were reported or anticipated.
 
Manufacturer Narrative
Device code is no longer applicable for this event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare provider (hcp) on 2018-sep-20. The cause of the inability to inject dye into the catheter access port (cap) was not determined. Regarding actions/interventions taken or planned to resolve the inability to inject dye into the cap, the hcp reported they have decreased the pump significantly and will have repeat trials around the catheter. Regarding the report that the catheter was cleared of drug for the dye study, but was not primed afterward, the hcp reported the circumstances that led to the catheter not being primed included the following: the neuro-radiologist did the procedure. The radiologist did not know the catheter was supposed to be primed after the procedure and did not have a programmer. Therefore, no programmer was involved. Actions taken to correct/resolve the issue included a variance report, and close monitoring of the patient in ¿n/mu¿ (hospital). Regarding the report from the friend/family member that the patient¿s pump had malfunctioned after an mri and was ¿locked,¿ the hcp clarified there was no device issue or problem with the pump. The hcp indicated there were no stalls on the log. The hcp also stated a pump alarm did not occur. The patient was being titrated down. There were no significant withdrawals or increase in tone. The patient¿s status at the time of the report was provided as ¿inpatient/stable. ¿ the patient¿s symptoms had resolved.
 
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. It was unknown when the system was removed, and it was unknown if the pump and catheter would be returned to the manufacturer for analysis.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the consumer on 2018-nov-19. The consumer reported the patient had also experienced withdrawal symptoms. The consumer stated they did not know if the system was removed on (b)(6) (2018). The consumer indicated they were still seeing some of the same symptoms since the system had been removed. It was indicated the patient had not really been himself. The patient was agitated and would pull his clothes off and hit his head. The consumer stated they have not followed-up with the healthcare provider yet. The consumer was redirected to follow-up with the healthcare provider regarding the patient's symptoms.
 
Event Description
Additional information was received from the consumer on 2018-oct-16. It was reported the patient had experienced confusion, along with the previously reported symptoms. The consumer stated they were first told that it was not the pump causing the patient's symptoms. Then the healthcare provider (hcp) did a dye test over a week and a half ago, or "something like that" (relative to the date of the report, 2018-oct-16), and the dye study showed "it was blocked, it was conclusion whatever you call it. " the healthcare provider removed the whole system. The consumer thought it was on oct 5th. The consumer stated the patient was getting worse now.
 
Manufacturer Narrative
The other relevant component includes: product id 8781 lot/serial# (b)(4) implanted: (b)(6)2018, explanted: (b)(6) 2018, product type catheter. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key7870106
MDR Text Key120004714
Report Number3004209178-2018-20477
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169530126
UDI-Public00643169530126
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/12/2018 Patient Sequence Number: 1
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