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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 Problems Insufficient Flow or Under Infusion (2182); Insufficient Information (3190)
Patient Problems Muscular Rigidity (1968); Pain (1994); Ambulation Difficulties (2544)
Event Date 04/01/2020
Event Type  malfunction  
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 baclofen via an implanted pump. It was reported that the patient thought his pump was not working because there was a recall on his pump. He stated that since the beginning of this year (b)(6) 2020 the pump stopped working. His symptoms changed and he knew he wasn¿t getting the medicine. Then 1. 5 days later (also stated as 24-30 hours later) he went back to being fine/normal again. He stated that he wasn¿t sure if the pump had stopped or if there had been a ¿kink in the line or something¿. Then it was time for a pump refill about a month later and he told his doctor what was going on. The doctor removed the medication and refilled the pump, and the doctor rechecked the pump and nothing showed any kind of trouble. The patient stated that he told the doctor the pump never alarmed and he knew what that was like ¿because they had run the pump dry and run the pump on saline at one point¿ so he knew what symptoms he had when he was not getting the baclofen. Per the patient, ¿that has happened to me at least twice¿. He stated that he knew he was not getting any medication because he was walking flatfooted and had pain back in his hip area (complete hip area). He also had leg spasticity. Per the patient, they had not done a catheter dye study on his pump. The patient also stated that the pump had stalled twice and now it was working. It was reviewed with the patient that the doctor could pull the records from the pump which would show if the pump stalled. He then stated that the doctor did pull the pump records and the pump did not show the pump stalled. The pump records didn¿t show any sort of trouble.
 
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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 Key11002185
MDR Text Key221494487
Report Number3004209178-2020-21745
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 12/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2020
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 Received12/08/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/14/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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