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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 Kinked (1339); Migration or Expulsion of Device (1395)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 03/01/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8781, lot# n702110001, implanted: (b)(6) 2017, product type: catheter. Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), (b)(6), (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare professional (hcp) via daiichi regarding a patient who was receiving gabalon with an unknown concentration at 50 mg/day via an implantable pump for cerebral hemorrhage. It was reported that the itb pump system was performed on (b)(6) 2017 and after the operation spasticity was removed and perspiration has subsided. It was reported that the procedure was effective. In the beginning of (b)(6) 2018, it was reported that although the dose was increased the effect was weak. On (b)(6) 2018 catheter fluoroscopy was performed. It was noted that although the test was done as suspected, the detachment of the connector part, the contrast media was not confirmed at the connector part. The contrast media was confirmed at the intrathecal space. It was noted that the patient was to follow-up observation. On (b)(6) 2018, it was reported that no improvement in spasticity was observed and 3d-ct examination, dsa contrast examination, ct examination were performed. It was reported that displacement of catheter to the epidural area and kink at the anchor puncture part were suspected by ct images after 3d-ct and contrast examination. It was noted that it seemed that there was a possibility that the catheter of the anchor puncture part was kinking because the catheter was pushed too much when the catheter was fixed with the anchor dispenser. It was reported that the event was unrecovered. The classification of severity of the event was reported as 3 (serious). The causality was reported as unrelated to the drug, catheter, pump and programmer and related to the surgical procedure. No further complications were reported and/or anticipated. Additional information was received from a foreign hcp via a manufacturer representative. It was reported that no surgical intervention or planned surgical intervention was reported at this time. It was reported that there were no reported contributing factors at this time. It was reported that the patient was recovering. It was noted that in the case that any device would be explanted, it would be discarded by the customer and would not be returned. No further complications were reported and/or anticipated.
 
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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 Key7504067
MDR Text Key108277513
Report Number3004209178-2018-10615
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2018
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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