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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 Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Itching Sensation (1943); Muscle Spasm(s) (1966); Muscle Weakness (1967); Muscular Rigidity (1968); Overdose (1988); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Sleep Dysfunction (2517)
Event Date 09/13/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 8781,serial# (b)(4), implanted: (b)(6) 2019, product type catheter. Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 23-jul-2021, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a company representative (rep) regarding a patient receiving unknown baclofen (concentration and dose unknown) via an implanted pump. It was reported the patient was having erratic therapy. It was unknown when the event/difficulty occurred, but the rep would follow-up for more information. It was reported per the doctor, the patient got stiff, then too loose per the patient¿s mother. It was noted the doctor was frustrated and had decided to replace both the catheter and battery. It was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue. A dye study was performed in november and showed the catheter was intact. The plan was to replace the pump and catheter. It was further reported the rep would get all the details at the revision case. Surgical intervention was planned for (b)(6) 2020. The issue was not resolved at the time of this report and the patient¿s status was ¿alive-no injury. ¿ the rep would follow-up for the patient¿s weight and medical history on (b)(6) 2020. 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 Key10106422
MDR Text Key196069863
Report Number3004209178-2020-09481
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
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/28/2021
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2019
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: 06/01/2020 Patient Sequence Number: 1
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