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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 8637-20
Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Patient Problem Granuloma (1876)
Event Date 11/04/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8731, serial#:(b)(4), implanted: (b)(6) 2020, product type: catheter. Other relevant device(s) are: product id: 8731, serial/lot #: (b)(4), ubd: 14-feb-2007, udi#:(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a device manufacturer representative regarding a patient receiving morphine (40 mg/ml at 12. 5mg/day) and "mixture of clonidine and marcaine" but the representative wasn't sure, via an implantable infusion pump. It was r eported that the patient has an inflammatory mass at her l5-s1 spinal area and a dye study was being done to check the catheter. The dye study was performed and showed that the dye appeared to go retrograde and the catheter appeared to be in the lower area of the spine, around l5-s1. There appeared to be a "tip" from an old catheter in the thoracic area, but no dye reached that area. Dye stayed in the lower lumbar area. The doctor planned to wean the patient down and then do a catheter revision. The patient had no therapy complaints and was getting good pain relief. The issue was not resolved. 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 Key10809943
MDR Text Key215340131
Report Number3004209178-2020-19588
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 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/01/2018
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: 11/09/2020 Patient Sequence Number: 1
Treatment
"SEE H10...."
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