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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 Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045)
Event Date 11/14/2017
Event Type  Injury  
Manufacturer Narrative
Corrected to accurately reflect the information received on 2017-nov-16. 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 baclofen at an unknown concentration and dosage via an implantable pump for intractable spasticity. On (b)(6) 2017, it was reported that the patient was admitted to the hospital and then moved to the icu after they were found barely breathing. It was noted that the patient had had their pump filled on (b)(6) 2017. When the consumer found the patient on (b)(6) 2017, they could not get a blood pressure on the patient. No out of box failures were reported. No medical or therapy problems associated with small parts were reported. The consumer inquired about possible recalls on the pump. No further complications were reported.
 
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 baclofen at an unknown concentration and dosage via an implantable pump for intractable spasticity. On (b)(6) 2017, it was reported that the patient was admitted to the hospital and then moved to the icu after they were found barely breathing. It was noted that the patient had had their pump filled on (b)(6) 2017. When the consumer found the patient on (b)(6) 2017, they could not get a blood pressure on the patient. No out of box failures were reported. No medical or therapy problems associated with small parts were reported. No further complications were reported.
 
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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 Key7062386
MDR Text Key103311752
Report Number3004209178-2017-24417
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 Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 11/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/14/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/16/2015
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: 11/27/2017 Patient Sequence Number: 1
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