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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 Kinked (1339); Obstruction of Flow (2423); Material Integrity Problem (2978)
Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271)
Event Type  Injury  
Manufacturer Narrative
Product id: 8780, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #:(b)(4), ubd: (b)(6) 2018, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a company representative regarding a patient who was receiving a compounded baclofen with concentration 2000 mcg/ml at a dose rate of 1100 mcg/day and bupivacaine with concentration 20 mg/ml at a dose rate of 10. 9 mg/ml via an implantable pump for intractable spasticity. It was reported that the patient experienced a return of spasticity. Diagnostic tests / troubleshooting performed in the operating room included a motor study and dye study. The rotor test showed the pump was fine; however, the pump segment of catheter showed a shear and after the anchor there was a kink. The event occurred during normal use. The date of event was unknown. The pump and complete catheter were explanted and replaced. Regarding environmental/external/patient factors that may have led or contributed to the issue, it was noted that the patient was very active. The issue was resolved at the time of the report. The patient was without injury regarding their status at the time of the report. The patient¿s weight and medical history were noted as having been requested but were unknown. The company representative was in possession of the explanted device which was planned to be returned to the manufacturer. Other medications (oral, etc. ) the patient was taking at the time of the event was unable to be obtained. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter. Correction: the pump serial number was corrected from being (b)(4), and as a result the expiration date and implant date were corrected. Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. Due to imdrf harmonization, the previously applied device (b)(4) is no longer applicable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider via a company representative. The pump rotor study was performed with no issue found and the dye study however showed no spread; catheter was broke at proximal end with shear and a kink was at the anchor site. The patient had recovered without sequela regarding their status after the device was removed. The device was returned to the manufacturer for analysis.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Analysis of the catheter on (b)(6) 2018 revealed a hole in the catheter body caused by repeated flexing and also damage to transition tube. The conclusion code pertains to the analysis finding of a hole caused by repeated flexing. The conclusion code pertains to the analysis finding of damage to the catheter¿s transition tube. 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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7650352
MDR Text Key112729037
Report Number3004209178-2018-14646
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2016
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: 06/29/2018 Patient Sequence Number: 1
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