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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 Problem Excess Flow or Over-Infusion (1311)
Patient Problems Dyspnea (1816); Fatigue (1849); Overdose (1988); Pain (1994); Vomiting (2144); Complaint, Ill-Defined (2331); Loss of consciousness (2418)
Event Date 06/22/2018
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 consumer regarding a patient receiving an a unknown drug with an unknown dose and concentration via an implantable pump for non-malignant pain. It was reported the device was overdosing. No symptoms were reported. The event date was unknown. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) on 2018-sep-26 indicated the cause of the patient's overdose and symptoms was unknown. Actions/interventions to resolve the patient over dose and symptoms included the hcp observed the patient, reduced the dose, and disabled the patient's personal therapy manager (ptm). The cause of the pump "dosing something wrong" was unknown. Actions/interventions to resolve the pump dosing something wrong was the patient was taken back to the operating room to check side port. It was noted that everything was normal. The cause of the inability to aspirate the catheter during a dye study was not determined. It was noted they were able to do so in the operating room. No actions/interventions were taken to resolve the inability to aspirate the catheter during a dye study. It was noted that there was no catheter replacement and the catheter was still implanted. The patient's weight was unknown. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from consumer on 2018-oct-05 indicated the device overdosing the patient was first noted on (b)(6) 2018 (please note: this conflicts with previously reported information that the event date was (b)(6) 2018). The patient's weight was noted as (b)(6) pounds. The patient noted they "pasted"/passed out and went to the emergency room twice on (b)(6) 2018 and on (b)(6) 2018. The circumstances that led to the device overdosing was first fill after the device was installed. Steps taken to resolve the overdosing included the "personal therapy manager (ptm) was stopped and went down on constant and bolet. " the patient noted that the overdosing had been resolved. No further complications were reported/anticipated.
 
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 2019-jan-04. The patient stated the previous report that the pump was giving too much medication "was not correct. " the patient stated, "what i found out later, the real reason why it happened, is they put me on 'mobantic,' and i had stopped 'mobantic' which caused a rush of medication. " the patient stated they were still working with their healthcare provider to go down on the medication and they were still getting too much ['mobantic'].
 
Manufacturer Narrative
Product id 8780, serial# (b)(4). Product type catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient receiving fentanyl (2000 mcg/ml at 988 mcg/day), bupivacaine (5 mg/ml at 2. 4699 mg/day), and baclofen (800 mcg/ml at 395. 18 mcg/day) via an implantable infusion pump. It was noted that the patient was on baclofen because his legs were kind of "screwy". The indication for use was non-malignant pain. It was reported that the patient thought the pump was doing something wrong. The caller stated that it seemed like it was working after being implanted but that he felt like they needed to increase the medication but not by much. It was noted that after the pump was installed a dye study was attempted but they could not get the mediation out of the catheter so it was aborted. It was reported that the healthcare provider (hcp) was not concerned and continued to increase the patient's medication. The caller stated that the medication were starting to get to the point where they were "dialed in". The first pump refill was on (b)(6) 2018, the pump was increased by 4. 5 percent and the personal therapy manager (ptm) bolus was changed from every 2 hours to every hour. Within 24 hours after they performed the refill the patient ended up in the emergency room (er) two times (on (b)(6) 2018 and (b)(6) 2018). The reason behind the er visits was due to the patient passing out because of a sudden overdose; the patient felling like he was getting too much medication and that when they filled the pump whatever was causing the dye study to be aborted fixed itself and he began getting the full dose of medication. It was noted that the patient was getting drowsy, was out of it, throwing up, had a hard time catching his breath and could not poop. It was noted that the patient was also on oral medications because he had problems with his neck but that he was stripped down from "taking 4¿now none at all". The caller stated that the medication is either building up in his system because at 15:00, 17:00, and 23:00 he gets the feeling of being over medicated. It was stated that on friday they turned off the patient's ptm because the healthcare provider (hcp) thought it was being used too much and causing the problem. The caller reported that yesterday the pump was decreased by 10 percent and that he had a lot more pain and then around 15:00 or 16:00 he felt like he was getting too much medication and then the pain went away. A device manufacturer representative came to the hcp office yesterday and did not find any issues with the infusion system. The caller stated that he is going to the hcp tomorrow for a refill appointment because they think he got a bad batch of medication and that the catheter was being replaced on (b)(6) 2018. No further complications have been reported as a result of this event.
 
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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
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 Key7882492
MDR Text Key120459644
Report Number3004209178-2018-20829
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169530126
UDI-Public00643169530126
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/05/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/17/2018 Patient Sequence Number: 1
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