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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Fluid Leak (1250); Kinked (1339); Volume Accuracy Problem (1675)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 03/30/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant product(s): product id: 8781, lot# serial# (b)(6), implanted: (b)(6) 2013, product type: catheter. Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 24-may-2015, udi#: (b)(4). (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 clinical study regarding a patient receiving dilaudid (1. 5 mg/ml at 0. 3600 mg/day) and bupivacaine (30. 0 mg/ml at 7. 200 mg/day) via an implanted pump. The indication for use was non-malignant pain. It was reported the patient presented for a pump adjustment secondary to increased lower back pain on (b)(6) 2018. A reservoir volume discrepancy was noted at the patient's last refill, on (b)(6) 2018, in which there was a 3 ml discrepancy. The device was interrogated, on (b)(6) 2018, and a 3 ml reservoir volume discrepancy was noted. During the scheduled pump replacement surgery, on (b)(6) 2018, secondary to the worsening pain and pump reservoir volume discrepancy the healthcare provider (hcp) opened the pump pocket and clear fluid looking like csf, ¿poured¿ from the wound. The proximal catheter appeared to be kinked. The sutureless catheter connector was replaced and a new proximal segment attached to the new pump. The pump was then anchored. The side port was accessed and the implanter was unable to aspirate csf. Dye was injected and the entire catheter was under fluoroscopy. A leak was identified at the catheter anchor. The spinal segment was replaced. The clinical diagnosis was worsening pain and decreased therapeutic relief. It was indicated the event was related to the device or therapy. The issue resolved without sequelae on (b)(6) 2018.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare provider via a clinical study reported the patient's weight was 183 lbs. The cause of the catheter leak was not determined.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7518265
MDR Text Key108390734
Report Number3004209178-2018-11024
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 health professional,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2015
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 Received06/04/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/15/2013
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: 05/16/2018 Patient Sequence Number: 1
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