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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); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Material Integrity Problem (2978); Unintended Movement (3026)
Patient Problems Twiddlers Syndrome (2114); Therapeutic Response, Decreased (2271); Underdose (2542)
Event Date 07/11/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2004, product type: catheter. Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 28-jul-2006, udi#: (b)(4). Initial reporter occupation: non-healthcare professional. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer and a company representative regarding a patient receiving morphine (25 mg/ml at 3mg/day) via an implanted pump. The indication for pump use was non-malignant pain/other non-malignant pain. It was reported that the patient began having withdrawal on (b)(6) 2018. The patient was being taken to surgery on monday ((b)(6) 2018). On (b)(6) 2018 the patient reported that they found out that the ¿tube was crossed¿ and because of this, he was not getting the correct dose of morphine. Per the patient, it had taken 5-6 days to figure out what was wrong, but the neurosurgeon fixed it. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product id 8709, serial# (b)(4), implanted: (b)(6)2004. Product type catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer's representative (rep). It was reported that the patient may be a twiddler. No further complications were anticipated/reported.
 
Event Description
Additional information was received from the consumer indicated that the catheters had crossed again on (b)(6) 2018. It was reported that the pump had been moving. No further complications have been reported as a result of this event.
 
Manufacturer Narrative
Concomitant medical products: product id 8709, serial# (b)(4), implanted: (b)(6) 2004, explanted: (b)(6) 2018, product type catheter. If information is provided in the future, a supplemental report will be issued.
 
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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
MDR Report Key7730928
MDR Text Key115359931
Report Number3004209178-2018-16892
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/30/2018 Patient Sequence Number: 1
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