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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 Excess Flow or Over-Infusion (1311); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883)
Patient Problems Overdose (1988); Pain (1994); Therapeutic Response, Decreased (2271); Loss of consciousness (2418); Lethargy (2560)
Event Date 04/03/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8731sc, serial# (b)(4), implanted: (b)(4) 2011, product type: catheter. Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 05-may-2013, (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) and manufacturer representative (rep) regarding a patient who was receiving 20 mg/ml dilaudid at 2 mg/day, 700 mcg/ml clonidine at 70 mcg/day, and 21 mg/ml bupivacaine at 2. 1 mg/day via an implantable pump for non-malignant pain. It was reported that on the night of (b)(6) 2018, the patient had been using their personal therapy manager (ptm) overnight and it was not relieving her pain like it usually did. On wednesday [(b)(6) 2018], the patient fell asleep and the daughter could not wake her up. The patient had a second incident on thursday where she fell asleep in the emergency room and the doctors had a hard time arousing her. It was noted that the expected residual volume was 17 ml and the actual residual volume was 0 ml. It was stated that the physician believed these were instances of overdose and that was why the pump was empty. The patient's refill was a month or more ago. They aspirated the reservoir and filled with preservative free normal saline and a bridge bolus was programmed around 11:45 pm saturday night. It was noted they were unable to aspirate the catheter. The rep was going to speak with the patient and decide whether they were going to replace the pump. Withdrawal was also noted. The patient was being given oral medication, but it was not making a dent on the pain. The patient was noted to be in the hospital with iv medication. It was later reported that the hcp wanted to restart the pump with the "normal medication dosage" and wanted to know how much drug was left in the catheter. No further issues were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp). No cause of the volume discrepancy was determined. The cause of the inability to aspirate was also unknown. 10 ml of saline was inserted into the pump and a bridge bolus was initiated and the event was considered to be resolved. The device was working well and the refill was done. No further issues were reported or anticipated.
 
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) and manufacturer representative (rep) regarding a patient who was receiving 20 mg/ml dilaudid at 2 mg/day, 700 mcg/ml clonidine at 70 mcg/day, and 21 mg/ml bupivacaine at 2. 1 mg/day via an implantable pump for non-malignant pain. It was reported that on the night of (b)(6)2018, the patient had been using their personal therapy manager (ptm) overnight and it was not relieving her pain like it usually did. On wednesday [(b)(6)2018], the patient fell asleep and the daughter could not wake her up. The patient had a second incident on thursday where she fell asleep in the emergency room and the doctors had a hard time arousing her. It was noted that the expected residual volume was 17 ml and the actual residual volume was 0 ml. It was stated that the physician believed these were instances of overdose and that was why the pump was empty. The patient's refill was a month or more ago. They aspirated the reservoir and filled with preservative free normal saline and a bridge bolus was programmed around 11:45 pm saturday night. It was noted they were unable to aspirate the catheter. The rep was going to speak with the patient and decide whether they were going to replace the pump. Withdrawal was also noted. The patient was being given oral medication, but it was not making a dent on the pain. The patient was noted to be in the hospital with iv medication. It was later reported that the hcp wanted to restart the pump with the "normal medication dosage" and wanted to know how much drug was left in the catheter. No further issues were reported or anticipated. Additional information was received from a healthcare professional (hcp). No cause of the volume discrepancy was determined. The cause of the inability to aspirate was also unknown. 10 ml of saline was inserted into the pump and a bridge bolus was initiated and the event was considered to be resolved. The device was working well and the refill was done. No further issues were reported or anticipated.
 
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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 Key7426322
MDR Text Key105320061
Report Number3004209178-2018-07907
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169530126
UDI-Public00643169530126
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 04/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2019
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 Received04/25/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/23/2017
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: 04/12/2018 Patient Sequence Number: 1
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