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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 Insufficient Information (3190)
Patient Problems Fall (1848); Pain (1994); Tingling (2171); Therapeutic Response, Decreased (2271); Discomfort (2330); Injury (2348); Ambulation Difficulties (2544)
Event Date 07/12/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical product: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter. Other relevant device(s) are: product id: 8780, 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 consumer and healthcare professional (hcp) via a company representative regarding a patient receiving morphine (25 mg/ml at 5. 502 mg/day) via an implanted pump. The indication for pump use was non-malignant pain. On (b)(6) 2018 it was reported that the patient¿s infusion system was originally implanted for left leg sciatica and was helping. A month to 6 weeks ago the patient started having tingling in her toes. She then had pain in both legs and her left leg was ¿way worse¿. She couldn¿t stand, she had to lay to get comfortable. It got worse after a 6 hour car ride this weekend. On sunday ((b)(6) 2018), she fell and hit her head because she was unsteady on her legs. It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue. On (b)(6) 2018, the patient was taken to surgery at which time the back incision was opened and they pulled the catheter down slightly. It was noted that it seemed to veer to the right. The issue was resolved at t he time of the report. The patient status was reported as ¿alive ¿ no injury¿. It was indicated that the hcp had no further information regarding the event. No further complications were reported/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 Key7812448
MDR Text Key118106078
Report Number3004209178-2018-19087
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,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/18/2017
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: 08/24/2018 Patient Sequence Number: 1
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