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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 Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Patient Problems Bruise/Contusion (1754); Muscle Weakness (1967); Muscular Rigidity (1968); Paralysis (1997); Scar Tissue (2060); Urticaria (2278); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 08/17/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 8781 lot# serial# (b)(4), implanted: (b)(6) 2014, product type: catheter. Product id 8781 lot# serial# (b)(4), implanted: (b)(6) 2014, product type: catheter. Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 11-nov-2016, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2021, information was received from a patient via a manufacturer representative (rep). The patient was receiving baclofen (2,000 mcg/ml, 361 mcg/day) via an implantable pump for intractable spasticity. It was reported that the patient had, what they thought was an insignificant fall onto a golf cart last wednesday and after that, they started having some increased spasticity. On thursday, they saw their physician and started also having clonus to left leg along with some weakness of that leg. The patient was admitted for monitoring. They were started on supplemental oral baclofen. On friday, the patient also complained of urticaria. Per the patient, a ct scan was performed last friday that showed the catheter in the correct spot. The patient was ordered for a dye study on the date of this report. The hcp accessed the catheter access port (cap) and was unable to aspirate the catheter so the dye study was then terminated. The patient was to be transferred to a sister hospital and would have a catheter revision soon. The issue was not resolved at the time of this report.
 
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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 Key12339206
MDR Text Key267164387
Report Number3004209178-2021-12603
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,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2022
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received11/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/05/2021
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: 08/18/2021 Patient Sequence Number: 1
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