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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 Problem Infusion or Flow Problem (2964)
Patient Problems Seroma (2069); Cramp(s) /Muscle Spasm(s) (4521)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 8780 lot# serial# (b)(4) implanted: (b)(6) 2015 explanted: (b)(6) 2022 product type catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 08-jan-2017, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient via company representative (rep) who was receiving baclofen (500 mcg/ml at 267. 05 mcg/day) via an implantable pump for intractable spasticity and spinal cord injury/spinal cord disease. It was reported that the patient presented to the emergency room with withdrawal symptoms, has been suffering for over a week with spasms, and stated that they were not getting any therapy relief. In addition, their pump pocket was visibly distended and filled with fluid. The healthcare provider interrogated the pump on (b)(6) 2022 and the pump test was fine.  a factor that may have led or contributed to the issue was the report of a potential pocket fill. Of note, the patient stated that the catheter was separated from the pump.  a cap (catheter access port) access dye study was performed. Approximately 35 ml was aspirated directly from the pocket, this fluid was sent to the hospital lab for analysis. The catheter was then aspirated, and the dye injected. No visible leaks were noted at the pump/catheter connection piece. At the catheter tip, a small amount of dye was visualized being delivered only on right side of catheter. The physician noted that more force was required than normal to get dye out of catheter tip. The procedure ended and the pump was programmed to dosing equal to the start of procedure.  no additional measures at this time. The current plan was to have the patient back on friday ((b)(6) 2022) to access refill port to verify volume in pump matches what was programmed. This plan investigates the possibility of pocket fill at the patient's most recent refill. The issue was not resolved at the time of report. The patient's weight was asked but unknown. The patient's medical history included spinal cord injury t8. The patient's status at the time of report was alive - no injury. Additional information received from a healthcare provider (hcp) via company representative (rep) reported that the reservoir volume programmed matched the actual reservoir volume when the pump was emptied on (b)(6) 2022. A pump refill was performed after confirming volume accuracy. There was no definitive device issue determined at this time. The catheter was replaced on (b)(6) 2022 with a new 8780 catheter that was patent and allowed free flow of csf (cerebrospinal fluid).
 
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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 Key14744817
MDR Text Key294504932
Report Number3004209178-2022-07853
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,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received06/17/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/27/2021
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: 06/20/2022 Patient Sequence Number: 1
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