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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); Component Missing (2306); Connection Problem (2900); Infusion or Flow Problem (2964)
Patient Problems Muscular Rigidity (1968); Irritability (2421); Sleep Dysfunction (2517); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 05/16/2020
Event Type  Injury  
Event Description
Information was received from multiple sources (healthcare provider, clinical study) regarding a patient who was receiving gablofen via an implantable pump for unknown indications for use. It was reported that the patient experienced baclofen withdrawal symptoms: increased tone, irritability, insomnia, and increased involuntary body movement. The patient's symptoms led them to be an in-patient in the hospital. The increased tone was thought to be related to the low volume in pump due to an upcoming alarm date but the symptoms continued. The medication was increased from 157 to 580 mcg/day. Multiple volume discrepancies were noted to have occurred: (b)(6) 2021 the expected reservoir volume (erv) was and the actual reservoir volume (arv) was 10 ml, (b)(6) 2021 erv was 2. 2 ml and the arv was 9. 1ml, (b)(6) 2021 the erv was 5. 1 ml the arv was 10. 1 ml, (b)(6) 2021 the erv was 5. 8 ml and the arv was 12 ml, (b)(6) 2021 the erv was 3. 6 ml and the arv was 10. 5 ml and (b)(6) 2022 the erv was 3. 4 ml and the arv was 11 ml. A dye study was completed on (b)(6) 2021 and the catheter access port was unable to ab aspirated. The issue was ongoing. Catheter replacement was not completed at this time due to concern of hospitalization during covid surge.
 
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, product type: catheter. The main component of the system. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 11-feb-2021, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
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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 Key13758118
MDR Text Key290157212
Report Number3004209178-2022-03196
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 Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2022
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? Yes
Date Manufacturer Received04/19/2022
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

Patient Treatment Data
Date Received: 03/14/2022 Patient Sequence Number: 1
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