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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); Aspiration Issue (2883); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/20/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8781, lot# 0214850800, implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: catheter. Other relevant device(s) are: product id: 8781, serial/lot #: 0214850800, (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 a clinical study regarding a patient who was being implanted with an infusion pump for an unknown indication for use. It was reported on (b)(6) 2018 that the patient was implanted with an intrathecal catheter for a trial on (b)(6) 2018. On (b)(6) 2018, an implantable infusion pump was placed because of the positive trial. During this operation they did a ¿usual checkup¿ of the system by doing a side-port aspiration but they could not aspirate anything. Flushing was also not possible. The device diagnosis was a catheter kink. They could not find the reason for the obstruction and had to replace the catheter. The event also resulted in in-patient hospitalization. It was indicated the catheter would be returned. The etiology of the event was noted to be related to the device or therapy and not related to the implant procedure. The outcome was resolved without sequelae on (b)(6) 2018. No further complications were reported or anticipated.
 
Manufacturer Narrative
H6 device codes no longer apply to the event. Conclusion code was updated to 67. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a foreign healthcare professional (hcp) via a clinical study. It was reported the pump was delivering intrathecal baclofen 500,0 mcg/ml at 75,05 mcg/day.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received froma foreign healthcare professional (hcp) via a clinical study. It was reported the catheter w as not explanted/replaced, it was only revised. The catheter was still implanted and could not be returned to the device manufacturer.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received. The intervention of catheter explant/replacement was updated to catheter revision. This was reported to still have occurred on (b)(6) 2018. The etiology was updated to indicated the event was related to the lumbar/pump portion of the catheter, instead of the entire catheter.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a foreign healthcare professional (hcp) via a clinical study. It was reported the catheter was revised, and the etiology pertained to the lumbar/pump portion.
 
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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 Key7658950
MDR Text Key113034734
Report Number3004209178-2018-14906
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/23/2018
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: 07/03/2018 Patient Sequence Number: 1
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