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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); Unstable (1667); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)
Event Type  Injury  
Manufacturer Narrative
Information references the main component of the system and other applicable components are: product id 8780, serial# (b)(4), implanted: (b)(6) 2016, product type catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from an unknown source via a device manufacturer representative regarding a patient who was receiving an un known drug via an implantable infusion pump for post lumbar laminectomy syndrome and spinal pain. It was reported that the patient had been having sporadic to no pain relief. The pump was flipped and the catheter was kinked. The catheter was very coiled at the pump pocket. It was unknown when the patient's sporadic to no pain relief, pump flip, catheter kink, or catheter coil at the pump pocket started. The issue was diagnosed through surgical exploration, which occurred on (b)(6) 2018 during the revision, the healthcare provider (hcp) used a revision kit. The starting length was 73. 7 cm, and the hcp removed 54. 5 cm, which left 19. 2 cm. However, the hcp manually measured the pump segment to be implanted and it measured 18. 6 cm. The hcp was concerned about the 0. 6 cm discrepancy. No further complications were reported.
 
Manufacturer Narrative
The main component of the system and other applicable components are: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2016, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a device manufacturer representative. It was reported that the cause of the flipped pump and catheter kinking/coiling was not determined. The flipped pump and catheter kinking/coiling were resolved with surgery on (b)(6) 2018. Part of the catheter was explanted and replaced with a pump segment catheter. The cause of the catheter length discrepancy was not determined. The catheter length was calculated based on what the hcp trimmed and input under the catheter information. Per the hcp, there was not going to be a product return. 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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7324244
MDR Text Key101890654
Report Number3004209178-2018-04681
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,Followup
Report Date 03/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2018
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 Received03/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/21/2016
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: 03/08/2018 Patient Sequence Number: 1
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