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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 Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
Patient Problem Cramp(s) /Muscle Spasm(s) (4521)
Event Type  Injury  
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving baclofen via an implantable pump for intractable spasticity and cerebral palsy. It was reported that the catheter would not aspirate during study. The patient was having more spasms and the refill volumes were off. It was unknown if there were external factors that led to the event. The patient will be seen by a neurosurgeon to be evaluated and worked up for a catheter replacement. The event was not resolved at the time of the report.
 
Manufacturer Narrative
Concomitant medical products: product id: 8780; serial#: (b)(4); implanted: (b)(6) 2013; product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 22-apr-2015, 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 Key14400248
MDR Text Key292731669
Report Number3004209178-2022-06195
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2020
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/11/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/01/2019
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: 05/13/2022 Patient Sequence Number: 1
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