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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 8637-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Apnea (1720); Itching Sensation (1943); Overdose (1988); Seizures (2063); Loss of consciousness (2418); Sleep Dysfunction (2517); No Known Impact Or Consequence To Patient (2692)
Event Date 08/02/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical product(s): product id: neu_label_acc, lot#/serial# unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer (patient¿s mother) regarding a patient who was receiving lioresal of an unknown concentration at a dose rate of 1100 mcg/day via an implantable pump for intractable spasticity. The lioresal dose rate was noted as having been decreased later to an unspecified dose rate. It was reported that the patient became unconscious and then stopped breathing. The patient did not react to noxious stimuli either. They originally thought the patient sleeping a lot and that it was due to possible social changes/situations, but when the patient would not wake up and their face itched they called 911. The date of the event was (b)(6) 2019. The monday before the incident ((b)(6) 2019) a pump refill occurred, and the dose was increased 5-10%. The staff was going to intubate the patient and the patient did receive dopamine. The healthcare provider (hcp) thought the patient maybe had a seizure. It was noted that no eeg was done until after the patient was discharged from the hospital and they felt that was also wrong because of the seizure suspicion. It was noted that the staff needed to call the physician and they did not listen to them stating they had to stabilize the patient. The emergency department (ed) did not immediately call the pump follow-up physician or the manufacturer despite them telling the ed staff they needed to do that. It was noted that the ed staff pushed narcan and did not follow the protocol for intrathecal baclofen (itb) emergency procedures. It was stated that the manufacturer has a responsibility to supply physician programmers to the hospital and that all hospitals ed staff be trained or have regular in-services for itb emergency procedures. They were questioning whether the manufacturer trains ed staff and why the staff does not have a physician programmer device available to utilize. The consumer did not think there was any protocol in place for itb emergency procedures and was upset about that and legal action was being considered. Pertinent information was reviewed at the time of the report regarding the consumer¿s inquires. The itb representative was also emailed requesting a call back to the consumer to answer their questions regarding itb emergency procedures and in-service trainings and supplying physician programmers to ed staff. It was further reported that they needed a new current manufacturer patient identification (id) card. It was indicated that the old one was printed and sent 7 months after the second pump was implanted. It was indicated that there was a wrong name on the card and that the physician¿s name was on the back instead of the front of the patient id card. The date (b)(6) 2019 is considered an approximate date of event (year known only) regarding the issue with the id card. It was also indicated that the patient had a rash with margins that had nothing to do with the pump/therapy and was diagnosed with atypical melanoma when a biopsy was done. They had got a second opinion from another physician. That physician had made a large incision / performed surgery for the melanoma on the patient¿s left abdomen area and leg. No further patient 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 Key9427744
MDR Text Key169732752
Report Number3004209178-2019-23262
Device Sequence Number1
Product Code LKK
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,health professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/28/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/08/2017
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: 12/06/2019 Patient Sequence Number: 1
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