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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Granuloma (1876); Muscle Weakness (1967); Pain (1994); Complaint, Ill-Defined (2331); Numbness (2415)
Event Date 08/18/2018
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 8709, lot #: j10898r62, implanted: (b)(6) 2001, product type: catheter, ubd: 24-aug-2003, udi #: (b)(4). Product id: 8598a, serial #: (b)(4), implanted: (b)(6) 2011, product type: catheter, ubd: 06-apr-2013, udi #: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient receiving an unknown dose and concentration of morphine, clonidine, and another unknown drug via an implantable pump for non-malignant pain and chronic low back pain. It was noted the device was delivering a compound mixture. It was reported the patient was getting ready to have a magnetic resonance imaging procedure (mri) and was instructed by their healthcare provider to have a manufacturing representative (rep) check their pump after the mri. The mri was being done because the patient had a small granuloma at the tip of their catheter. The patient had previously had a computed tomography (ct) scan performed and now the neurosurgeon wanted to have an mri done. The patient stated they started having more symptoms in the past year and a ct scan noticed something small. The patient had a second ct scan six months later which identified the small granuloma at the tip of the catheter. The patient reported they had symptoms that were symptomatic of a granuloma. It was reported the granuloma was identified at some point in the past year, in 2018. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp) via manufacturer representative (rep). It was reported that the rep was going into a case to remove the granuloma. Mass was surgically removed. The granuloma was excised and the catheter tip was trimmed off; the hcp elected to remove the tip of the catheter. Morphine dose was 9mg/day and they lowered it to 6 mg/day. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the company representative (rep). The rep reported a magnetic resonance imaging procedure (mri) was performed on (b)(6) (2019). They were waiting for the neurosurgeon to read the report and determine the next step. The pump and catheter were still active and functioning in the patient. The rep indicated that if the devices were explanted they would return them. The information provided had been confirmed with the physician/account.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient via a company representative who reported that the patient¿s symptoms also included numbness and frequent falls. The issue was not resolved at the time of this report. It was unknown if surgical intervention was planned. The patient status at the time of this report was reported as ¿alive ¿ no injury¿. No further complications have been reported as a result of this event.
 
Manufacturer Narrative
Patient code (b)(4) is no longer applicable. The codes applied in method/result/conclusion, are only applicable for product id: 8709 lot# j10898r62; product type, catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare provider (hcp). It was reported the patient had experienced weakness and pain in their legs associated with the granuloma. The granuloma was associated with catheter model number 8709, lot number j10898r62. There were no known factors that may have caused or contributed to the formation of the granuloma. The granuloma was diagnosed six months earlier, relative to (b)(6) 2019. Regarding further actions/interventions taken or planned, the doctor was awaiting the neurosurgeon's decision.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received via a company representative. The explanted catheter component was discarded by the healthcare provider and therefore would not be returned to the manufacturer.
 
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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 Key8344766
MDR Text Key136316608
Report Number3004209178-2019-03334
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/28/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1151-2008

Patient Treatment Data
Date Received: 02/15/2019 Patient Sequence Number: 1
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