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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 Excess Flow or Over-Infusion (1311); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591); Aspiration Issue (2883); Infusion or Flow Problem (2964)
Patient Problems Diarrhea (1811); Nausea (1970); Pain (1994); Chills (2191); Therapeutic Response, Decreased (2271); Shaking/Tremors (2515); No Code Available (3191)
Event Date 05/01/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a manufacturer's representative (rep) regarding a patient receiving 24 mg/ml bupivacaine at a dose of 3. 601 mg/day and 20 mg/ml unknown morphine at a dose of 3. 001 mg/day via an implantable infusion pump for spinal pain. It was reported that the patient's actual reservoir volume (arv) was less than the expected reservoir volume (erv) in (b)(6) 2018. The arv was 0 and the erv was 6. 9. The hcp did not know of any history of volume discrepancies but she would have to check her notes to be sure. As troubleshooting, the reservoir was accessed. The hcp attempted to a side port study but was not able to aspirate so she did not do a dye study. They were going to schedule a replacement on monday ((b)(6) 2018) and they would send the pump back for analysis. Withdrawal symptoms of shaking, nausea, and trembling were reported. The patient was in the hospital and they gave the patient medication and the patient started to feel better, no further complications were expected or anticipated.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Corrected information: the indication for the infusion system use also included complex regional pain syndrome type i, rsd/causalgia-complex regional pain syndrome, and non-malignant pain.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer via a company representative (rep) indicated patient experienced a loss of therapy, withdrawal symptoms, chills, pain in bone, nausea, diarrhea, and loss of appetite. The rep had not spoken to the healthcare provider (hcp) yet, but she would be going in for the case on the date of this report. The rep was under the impression they would be replacing the pump; however, she did not know yet. It was unknown if the pump logs have been read. The reason for the call was to review repair kits if they needed to revise any portions of the catheter. The rep would follow-up with the hcp. The event date was about two weeks ago (2018). No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
Product id: 8578, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2018, product type: catheter; product id: 8709, serial# (b)(4), implanted: (b)(6) 2005, explanted: (b)(6) 2018, product type: catheter; product id: 8598a, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2018, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that the physician replaced everything on (b)(6)2018 including the pump and the catheters the patient had in them. The cause of the volume discrepancy, empty reservoir alarm and the inability to aspirate the catheter was not determined and the physician replaced all the old devices because the physician did not want to take any chances. No further complications were reported or anticipated.
 
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 Key7507949
MDR Text Key108032630
Report Number3004209178-2018-10716
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2016
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 Manufactured07/15/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1570-2014

Patient Treatment Data
Date Received: 05/11/2018 Patient Sequence Number: 1
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