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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 Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583); Unstable (1667); Insufficient Flow or Under Infusion (2182); Difficult to Advance (2920); Positioning Problem (3009)
Patient Problems Abdominal Pain (1685); Pain (1994); Scar Tissue (2060); Discomfort (2330); Complaint, Ill-Defined (2331); Underdose (2542)
Event Date 06/28/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer. It was reported that the patient was having some problems with the pump sticking out or protruding, which occurred about 60-90 days after implant. The pump was not coming through the skin, but was causing severe back pain and abdominal pain, which was worsening. The pump had continued to slide so it could be seen when looking down on his stomach. If something were to slide down the patient's chest, it would catch on the pump. It was difficult to wear a belt and tight fitting clothing because it was uncomfortable, which started after implant on (b)(6) 2017. The patient also reported that they could only get the catheter 1/3 of where it was supposed to be and did not get up as high as they hoped. It was also noted that the pump had been a big help in delivering the patient's medication. No further complications were reported.
 
Manufacturer Narrative
Product id 8780 lot# serial# (b)(4) implanted: (b)(6)2017 explanted: 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 and a device manufacturer representative indicated that the catheter was not in the intrathecal space and that the pump was placed poorly. It was reported that the pump and the catheter was partially replaced on (b)(6)2019. No further complications have been reported.
 
Manufacturer Narrative
Device information references the main component of the system. Other relevant device(s) are: product id: 8780, serial #: (b)(4), ubd: 2019-05-18, udi#: (b)(4). Correction: intervention required was selected in error regarding the initial report. The type of report was previously indicated as serious injury in error and should indicate malfunction instead. Update: (b)(4); refer also to mfr report number 3004209178-2019-14629 regarding a subsequent event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received via a consumer. The patient¿s previous pump was placed in the wrong place and the patient was not receiving medication due to the catheter not being placed in the spinal cord. Refer also to mfr report number 3004209178-2019-14629 regarding a subsequent event.
 
Manufacturer Narrative
Refers to the main device, the other relevant component includes: product id 8780, serial# (b)(4), implanted: (b)(6) 2017, product type catheter. Code-conclusion applies to the pump, code-conclusion applies to the catheter.
 
Event Description
Information was received from a consumer regarding a patient receiving 100 mcg/ml of gablofen at an unknown dose via an implantable pump for intractable spasticity. It was reported the pump placement was very uncomfortable. The symptoms occurred suddenly. The patient stated the bottom of the pump rubs on their pants and the pump was implanted very low. It was indicated the physician told the patient to wear bigger pants. It was also reported the catheter was not high enough. The patient stated when the doctor implanted the catheter they had to go in three different places when trying to insert the catheter because the catheter kept ¿curing on him. ¿ the patient stated they were only able to get the catheter up half as high as the doctor wanted. The patient reported they wanted to get the catheter to t3-t4, but put it at l1. It was indicated this occurred on (b)(6) 2017. Additionally, the patient mentioned he had been on baclofen for 27 years and passed the trial with flying colors. Regarding dosing, the patient indicated they were thinking of increasing the concentration to ¿1200,¿ and their next refill was scheduled for (b)(6). Regarding the patient¿s personal therapy manager (ptm) dosing information, the patient stated per their ptm, ¿4 of 1200. 4 mcg/day. ¿ no further complications were reported/anticipated. Additional clarification was provided. It was reported when the doctor was trying to insert the catheter they had to go in three different places because the catheter kept curling on him (not curing).
 
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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 Key6859868
MDR Text Key106064859
Report Number3004209178-2017-19214
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 10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2018
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 Received10/07/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/21/2017
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: 09/12/2017 Patient Sequence Number: 1
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