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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 Kinked (1339); Obstruction of Flow (2423); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)
Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271)
Event Type  Injury  
Manufacturer Narrative
Continuation of medical devices: product id 8782, serial# (b)(4), implanted: (b)(6) 2015, product type catheter. Product id 8780, serial# (b)(4), implanted: (b)(6) 2015, product type catheter. Information references the main component of the system. Other relevant device(s) are: product id: 8782, serial/lot #: (b)(4), ubd: 30-may-2016, udi#: (b)(4); product id: 8780, serial/lot #: (b)(4), ubd: 16-dec-2016, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was provided by a healthcare provider via a manufacturer¿s representative regarding an implantable intrathecal pump intended to deliver gablofen [3000 mcg/ml to 500 mcg/ml] at 819 mcg/day, indicated for intractable spasticity and cerebral palsy. It was reported that a difficulty occurred intra-operatively on (b)(6) 2018 during a intrathecal baclofen (itb) replacement case. It was reported that there was no cerebrospinal fluid (csf) back flow from the spinal segment of the catheter during an intrathecal baclofen replacement case. It was noted that existing catheter volume was 0. 151 ml, and the 41. 9 cm spinal segment "0. 09218. " the proximal piece of the catheter was attached to the pump and a back-table prime was done with the 500 mcg/ml of 0. 306 mls. The existing spinal segment had 3000 mcg/ml. The caller was requesting calculations for the modified bridge bolus of the spinal segment. Technical services reviewed pertinent info per caller's inquires including programming, troubleshooted with caller and confirmed calculations per caller's request. It was noted that the rep would confer with the healthcare provider. No medical symptoms were reported. Additional information was received from a manufacturer's representative on (b)(6) 2018. It was clarified that the patient was brought in to replace the 20cc pump with a 40 cc pump, as the patient had moved and transportation to and from the refill clinic is challenging. It was reported that upon replacement, they were unable to aspirate the catheter, so a back table prime was performed (0. 3 ml) in the operating room. It was reported that in pre-op, the mother of the patient stated that his efficacy had decreased and they suspected the catheter was "linked" or occluded. The surgeon attempted to introduce a new catheter; however, the patient has hardware from cervical spine to sacrum. Ultimately, they decided to just reconnect the existing catheter. The surgeon wanted to monitor the patient overnight. It was stated that the patient was discharged on saturday ((b)(6) 2018) and was recovering. The patient's weight at the time of the event is unknown. No further complications were reported or anticipated. Reference regulatory report #3004209178-2018-14057 for the manufacturer's report regarding the difficulty trying to replace the catheter.
 
Manufacturer Narrative
Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer's representative on 2018-jun-29. It was clarified that "link" was a typo and was supposed to say kink. Regarding the reported decrease in efficacy, it was clarified that the patient's mother stated that there had been a change in tone, but it was noted by the physician that disease had progressed. It was reported that the patient's tone is now under control. The rep stated that as far as she knew, the patient recovered well. No further complications were reported or anticipated.
 
Manufacturer Narrative
Device code no longer applies. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer's representative on 2018-jul-11. It was clarified that prior to the inability to aspirate during the pump replacement on 2018 (b)(6), no previous concerns with the catheter were stated at the time of surgery. Regarding the suspected kink or occlusion, it was stated that nothing was found. It was noted that there was no imaging of the catheter in-vivo.
 
Manufacturer Narrative
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
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 Key7627271
MDR Text Key111975077
Report Number3004209178-2018-14060
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 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/22/2014
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: 06/21/2018 Patient Sequence Number: 1
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