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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 Occlusion Within Device (1423); Volume Accuracy Problem (1675); Aspiration Issue (2883)
Patient Problems Fatigue (1849); Therapeutic Effects, Unexpected (2099); Dizziness (2194); No Code Available (3191)
Event Date 03/16/2018
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 8709, serial# (b)(4), implanted: (b)(6) 2003, product type: catheter; ubd: (b)(6) 2005, 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 manufacturing representative (rep) regarding a patient receiving 25mg/ml of morphine at 17 mg/day via an implantable pump for non-malignant pain. It was reported there had been higher than expected residual volumes in the pump. It was unknown if there had been any environmental /external/patient factors that may have led or contributed to the issue. It was reported ¿catheter study done and drug picked through to try to clear possible occlusion. ¿ the date of the event was provided as (b)(6) 2018. The physician planned to wait to see if the patient received relief. It was unknown if the issue had been resolved at the time of the report. It was unknown if surgical intervention had occurred. The patient¿s status at the time of the report was provided as ¿alive-no injury. ¿ no further complications were reported or anticipated. Other medication being taken at the time of the event, patient weight, and medical history were unknown.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturing representative (rep) (b)(6) 2018. The rep clarified that the report should have said "catheter dye study done and drug pushed through the catheter. " it was reported the patient had experienced slight light headedness. It was indicated the volume discrepancies began a few months earlier. The expected residual volume vs. The actual residual volume was not known. It was indicated no further actions have been taken or planned. The physician was still waiting to see if the occlusion was cleared by pushing saline through the catheter. It was unknown if the patient had received relief yet.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare provider (hcp) (b)(6)2018. It was reported the volume discrepancy had occurred on (b)(6)2018. The expected residual volume (erv) was 6. 1 milliliters (mls) and the actual residual volume (arv) was 11. 0 mls. It was reported a pump study was performed (b)(6)2018. The preoperative diagnosis was provided as "mechanical complications of intrathecal pump. " the postoperative diagnosis was also provided as "mechanical complications of intrathecal pump. " it was reported the "contrast was injected to the pump, which had high resistance, but there was a noticeable give away and then contrast injected easily. " the patient's weight was provided as (b)(6) and fluoroscopy had limited penetration. The physician studied the length of the catheter and the spinal fluid at the tip. The physician stated, "it was difficult determine whether contrast was coming out of the tip whether there was a myelogram. I injected a total of 6 ml of contrast thus was endowed. " the physician then injected 20 ml of normal saline. The physician then tapped the pocket with an 18-gauge needle after maintaining sterile prep. No fluid could be obtained. The physician injected another 6 ml of contrast and another 5 ml of saline. The patient became noticeably drowsy and the pupils would not pinpoint. The physician stated the residual on the catheter would have given him a 5. 4 mg bolus of marcaine and 250 mcg of fentanyl and suggested that the catheter was intact delivering that bolus. The physician was also able to "easily aspirate out the catheter with 10 ml of clear fluid suggesting the catheter and the spinal fluid even though contrast could not be identified clearly due to his body mass. " the pump was programmed to fill the dead space in the catheter. The physician concluded the catheter and pump were still intact. It was reported the patient's previously reported symptoms had resolved.
 
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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 Key7469824
MDR Text Key106866967
Report Number3004209178-2018-09519
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2017
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received05/02/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/09/2015
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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