MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, 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 Key: 7507949
• MDR Text Key: 108032630
• Report Number: 3004209178-2018-10716
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• 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 Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 07/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1570-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR