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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 Insufficient Flow or Under Infusion (2182); Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Diarrhea (1811); Headache (1880); Vomiting (2144); Discomfort (2330); Malaise (2359); Alteration in Body Temperature (4568); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/12/2021
Event Type  malfunction  
Event Description
Information was received from a consumer regarding a patient receiving morphine via an implantable pump. The indication for use was spinal pain. The patient¿s family member reported that they believed the pump has not been working correctly. Per the reporter about a week and a half ago, they had to take the patient to the er (emergency room) due to severe vomiting, diarrhea, very bad headaches, was freezing, patient kept yawning, was aching all over like they had the flu, and had bad abdominal pain. The healthcare provider at the er (emergency room) did a cat scan on the patient¿s stomach, but didn't find anything. Per the reporter, it started around the (b)(6). The reporter stated they tried contacting the healthcare provider¿s office, but were unable to get in touch with the patient¿s nurse that fills the pump. They were directed by the healthcare provider¿s office to contact the manufacturer and inquired if the pump could be checked remotely. The reporter noted that when the issues occurred, they didn't think of the pump then, and stated the patient might have had covid or food poisoning. The reporter was redirected to their healthcare provider to further address the issue. Additional information was received from the healthcare provider (hcp) indicated that at the time of refill the expected reservoir volume was 9 and the action reservoir volume was 30. A catheter dye study was performed and no flow was confirmed. A mri of the catheter was negative for any granulomas. The hcp suspected scar tissue or catheter obstruction; the cause was unknown. The patient was being weaned down and provided oral medication.
 
Manufacturer Narrative
Concomitant medical products: product id: 8709sc; product type: catheter. Product id: 8578; product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Concomitant medical products: product id: 8709sc; product type: catheter. Product id: 8578; 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 morphine via an implantable pump. The indication for use was spinal pain. The patient¿s family member reported that they believed the pump has not been working correctly. Per the reporter about a week and a half ago, they had to take the patient to the er (emergency room) due to severe vomiting, diarrhea, very bad headaches, was freezing, patient kept yawning, was aching all over like they had the flu, and had bad abdominal pain. The healthcare provider at the er (emergency room) did a cat scan on the patient¿s stomach, but didn't find anything. Per the reporter, it started around the 12th of november the reporter stated they tried contacting the healthcare provider¿s office, but were unable to get in touch with the patient¿s nurse that fills the pump. They were directed by the healthcare provider¿s office to contact the manufacturer and inquired if the pump could be checked remotely. The reporter noted that when the issues occurred, they didn't think of the pump then, and stated the patient might have had covid or food poisoning. The reporter was redirected to their healthcare provider to further address the issue. Additional information was received from the healthcare provider (hcp) indicated that at the time of refill the expected reservoir volume was 9 and the action reservoir volume was 30. A catheter dye study was performed and no flow was confirmed. A mri of the catheter was negative for any granulomas. The hcp suspected scar tissue or catheter obstruction; the cause was unknown. The patient was being weaned down and provided oral medication.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13118381
MDR Text Key285940405
Report Number3004209178-2021-19148
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
Report Date 12/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/18/2016
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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