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); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Overdose (1988); Tachycardia (2095); Reaction (2414); No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) and a manufacturer's representative (rep) regarding a patient receiving 1 mg/ml dilaudid at a dose of 0.2498 mg/day via an implantable infusion pump for non-malignant pain.It was reported that at initial pump implant 1-2 weeks ago the patient had saline put in the reservoir of their pump.On (b)(6) 2017 dilaudid was placed in the pump reservoir and instead of doing a 0.391 ml priming bolus, a 0.540 ml bridge bolus over the duration of 51 hrs and 53 min was programmed.The patient was in the emergency department (ed) and had overdosed and was receiving narcan.The symptoms resembled more of an allergic reaction to the intrathecal medicine but the hcp did not know for sure what the issue was.The patient had a fast heart rate, heavy breathing, and was responsive to the narcan.The narcan cleared up some of it but the hcp was still testing for other possible medical issues.The rep reported that the bridge bolus was not going to end until later in the afternoon of (b)(6) 2017.The pump was programmed to minimum rate and the bridge bolus was cancelled.The hcp reported that the patient did have a urinary tract infection (uti) that was diagnosed on (b)(6) 2017.Additional information was received on (b)(6) 2017 from a healthcare professional (hcp).It was reported that during a removing system contents procedure the hcp had already done 2 primes and aspirations of 0.15 mls and wanted to confirm the final prime.It was confirmed that the final prime would be the catheter volume only- pump tubing not included.

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: 8840, product type: programmer, physician.(b)(4).

Event Description

Additional information received on 2017-apr-10 from a healthcare professional reported a pain pump error.Previous information was reported that was previously mentioned.No further complications were reported/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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6360712
• MDR Text Key: 68404822
• Report Number: 3004209178-2017-04628
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2017
• Initial Date FDA Received: 02/27/2017
• Supplement Dates Manufacturer Received: Not provided; 04/10/2017
• Supplement Dates FDA Received: 04/14/2017; 10/02/2017
• Date Device Manufactured: 01/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR