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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 No Audible Alarm (1019); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182)
Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994); Therapeutic Response, Decreased (2271); Discomfort (2330); Sleep Dysfunction (2517)
Event Date 01/01/2019
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 who was receiving clonidine and dilaudid at unknown doses and concentrations via intrathecal drug delivery pump. The indication for use was noted as spinal pain. It was reported that there was an error made with the last refill on (b)(6) 2018, in that there was only enough medication for 45 days rather than the standard 90 days, however the patient was not notified of this. She had moved to (b)(6) however was planning to keep going back to (b)(6) for refills. She had a bad fall on (b)(6) 2019 and shattered her right leg, was hospitalized, and had an extensive surgery so she could not travel to get back for refill. She was scheduled for her next refill on (b)(6) 2019 and she called the healthcare provider (hcp) office and this was when she was notified that her pump was not filled with 90 days of medication. She did not know if the office staff even notified the hcp. She was still on bedrest and could not travel. The patient made arrangements with a home infusion agency, however they called her back and said that because the pump had been dry, the patient had to see the hcp first and run some testing. The patient had increase in pain in lower back and legs. It was a gradual change in symptoms. After speaking with the hcp office, the patient checked the pump with the personal therapy manager (ptm) and she saw a picture of an alarm and date of (b)(6) 2019. She never heard an alarm. On (b)(6) 2019, the patient had difficulty sleeping. On (b)(6) 2019, the patient was uncomfortable during the day, pain returned, and they were again having difficulty sleeping and started sleepwalking and that was when the patient fell and shattered her leg. No interventions were mentioned. The patient was trying to find a local hcp to assist in the situation. She had not heard from the managing hcp in (b)(6). There were no further complications reported at this time.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key8347824
MDR Text Key136492432
Report Number3004209178-2019-03415
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2017
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 Received11/10/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/19/2016
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: 02/18/2019 Patient Sequence Number: 1
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