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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 Problem Volume Accuracy Problem (1675)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 06/06/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer and a healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving hydromorphone 3 mg/ml; 0. 7002 mg/day via an implantable pump. Indication for use was non-malignant pain and post lumbar laminectomy syndrome. The date of the event was (b)(6) 2018. It was reported the pump had a volume discrepancy; volumes were unknown. The actual residual volume (arv) was greater than the expected residual volume (erv) at the pump refill. The patient had "slight withdrawal issues. " the pump logs were checked, and no problems were noted in the logs. A dye study was completed (b)(6) 2018 and "everything looked good" so they will continue to observe. The patient was currently doing well. No further complications were reported. Additional information was received from a healthcare professional (hcp) via a manufacturer representative. It was unknown when the patient first started experiencing withdrawal; no additional details were available. The hcp scheduled a dye study to confirm pump and catheter functioning appropriately. All looked great and there was no issue with the catheter. The actual residual volume and the expected residual volume were not available. The patient has been doing well per the physician. The patient¿s weight at the time of the event and medical history were not available.
 
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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 Key7600965
MDR Text Key112149373
Report Number3004209178-2018-13411
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
Report Date 06/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/06/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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