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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); Unstable (1667); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)
Event Date 09/08/2017
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2017, product type: catheter. Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 15-mar-2019, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a company representative regarding a patient who was receiving dilaudid with concentration 10 mg/ml at a dose rate of 2. 996 mg/day via an implantable pump for non-malignant pain. The patient¿s medical history included spinal stenosis of the lumbar region. It was reported that the patient has not received good pain relief since implant ((b)(6) 2017). The patient¿s managing pain physician aspirated 20 ml from pump during refill 1 month ago. At a previous refill it was 19 ml. It was further indicated that the pump flipped when the patient went in for the first refill after implant and the physician could manually flip/ manipulate pump. The patient did not remember specific dates; the date of the event/difficulty was unknown. The managing pain physician recommended the patient to an alternate physician for evaluation. A dye study was performed today ((b)(6) 2018) and the physician could not aspirate cerebral spinal fluid (csf). It was further noted that the catheter tip appeared to be at c7 and the catheter was away from spine at lower thoracic area with the use of fluoro. The physician scheduled a revision and was to contact a manufacturer representative with the date/time; representative updated. Surgical intervention did not occur and was not scheduled, but was planned. The issue was not resolved at the time of the report. The patient was without injury at the time of the report. Other medications the patient was taking at the time of the event was unable to be obtained. Regarding any environmental/external/patient factors that may have led or contributed to the issue, it was noted that there were no contributing factors. No further patient complications have been reported as a result of this event. The patient¿s medical history included: spinal stenosis of lumbar region.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider via a company representative. Regarding the volume discrepancy at the first refill, the company representative was informed by the physician¿s office that the first pump refill occurred on (b)(6) 2017. They had not been updated on a surgery date as of yet, moreover, the patient was scheduled to have a follow-up appointment with the physician concerning the dye study and plans on (b)(6) 2018. The company representative attempted to contact the alternate physician¿s office and had not yet been able to speak with someone. It was further noted that at the time of the dye study, the physician stated that he felt the pump needed to be anchored again and a catheter revision needed to be scheduled. The physician indicated they would contact the company representative/manufacturer when planned. The primary company representative was also updated. The patient continues to use the pump as ordered and was waiting for the revision, otherwise there was no additional information available at this time.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer¿s representative (rep) on (b)(6) 2018. It was reported that the device would not be returned because the hospital disposed of it. The information was confirmed with the physician/account. There were no further complications reported/anticipated.
 
Manufacturer Narrative
Product id: 8781, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received via a company representative. It was indicated that a pump replacement was performed on (b)(6) 2018. A company representative had assisted the physician with the procedure. Additional information was also later received from a healthcare provider via an alternate company representative on (b)(6) 2018. The cause of the pump having flipped, catheter having moved away from the spine, and volume discrepancy at refills was indicated as not having been determined. It was however noted that the patient was obese and had a lot of loose skin. The pump having flipped, volume discrepancy at refills, and catheter having moved away from the spine had been resolved. Both the pump and catheter were replaced on (b)(6) 2019. Regarding the patient¿s outcome, it was described that the patient seemed to be doing fine.
 
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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 Key7494505
MDR Text Key107599210
Report Number3004209178-2018-10348
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
Report Date 05/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2019
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received05/29/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/26/2017
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: 05/08/2018 Patient Sequence Number: 1
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