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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 Filling Problem (1233); Obstruction of Flow (2423); Human-Device Interface Problem (2949); Material Split, Cut or Torn (4008)
Patient Problems Abdominal Pain (1685); Pain (1994)
Event Date 07/18/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial/lot #: (b)(4), ubd: 07-oct-2021, udi#: (b)(4), implanted: (b)(6) 2020, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) regarding a patient who was receiving 2 mg/ml of morphine at 0. 5 mg/day via an implantable pump for non-malignant pain. On (b)(6) 2020, it was reported that the patient felt their pump "pull and turn" while they were stretching about a month prior to the date of the event. Shortly after this, it seemed like the patient's pain was getting worse. Their pain symptoms reportedly intensified and their abdomen was sore where the pump was located. The patient's refill clinic had trouble accessing the pump. A dye study was attempted, but could not be done because the pump was flipped. A pocket revision was done on (b)(6) 2020. During the revision, the doctor decided to remove the pump segment and 8. 5cm of the spinal segment of the existing catheter as it was very kinked from the pump rotation. All the sutures on the patient's pump were broken. New catheter pieces were added and the catheter access port was accessed to confirm intrathecal placement and patent catheter. The catheter was easily aspirated and the pump was resutured in the pocket. The removed catheter pieces were discarded. The issue was considered resolved at the time of the event. The patient's status was listed as "alive-no injury". No further complications were reported.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10428001
MDR Text Key205319063
Report Number3004209178-2020-14383
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
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2021
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 Received08/18/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/24/2020
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: 08/19/2020 Patient Sequence Number: 1
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