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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 Positioning Problem (3009)
Patient Problems Fatigue (1849); Vomiting (2144); Dysphasia (2195); Ambulation Difficulties (2544)
Event Date 04/30/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4). Implanted: (b)(6) 2020, product type: catheter. Other relevant device(s) are: product id:(b)(4), serial/lot #: (b)(4), ubd: 08-nov-2021, udi#: (b)(4).
 
Event Description
Information was received from a consumer regarding a patient receiving lioresal (2000 mcg/ml at 1075. 5 mcg/day) via an implanted pump. The indication for pump use was intractable spasticity. It was reported by the patients mother on (b)(6) 2021 that the patient had been having problems with the pump ever since it was implanted. The pump took away the patients ability to walk instead of helping her to walk. Per the reporter, she had also had an infection in her teeth since before the pump and now she had not really woken up or eaten anything for the last few days; she had not passed much besides a few urines; she had been vomiting; and she had been to the emergency room 3 times in the last 3 days. In (b)(6) 2020, she stopped talking and the ct scan that was done did not show anything. The patients mother was calling because she was wondering if oral antibiotics could cause the pump to over-infuse. Additional information was received on 28-may-2021 from the patients mother who reported that the patient was still having the same issues as previously reported. The patient had been to the er (emergency room) 5 times and hospitalized 10 times since implant and hadnt been able to sit up or use her legs for a year. She had also lost her speech. Per the patients mother, the patient had an appointment scheduled to have the catheter moved down as they felt the catheter was too high, but she believes the hcp (healthcare provider) was chickening out because the surgery had been moved. She was calling to ask where the catheter should be placed as it was currently at t5. Implant consideration were reviewed, and the patients mother was redirected to the patients hcp. She stated that another physician had initially implanted the pump and they may follow up with them.
 
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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 Key11964355
MDR Text Key255078914
Report Number3004209178-2021-09043
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
Report Date 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2021
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 Received05/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/21/2019
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: 06/09/2021 Patient Sequence Number: 1
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