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

Model Number 8637-20

Device Problem Failure to Interrogate (1332)

Patient Problems Overdose (1988); No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2017

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 manufacturer representative regarding a patient's implanted infusion pump containing unknown medication(s) at an unknown dose and concentration.The indications for use included non-malignant pain and degenerative disc disease/herniated disc pain.On (b)(6 2017, it was reported that the patient was admitted to the intensive care unit (icu) for reasons unrelated to the device or therapy.The patient's healthcare provider wanted to program the pump to minimum rate while the patient was there, but was unable to interrogate the pump.Two different clinician programmers were used, as well as foil, a lead collar, and a lead apron folded over several times, in order to shield the pump from potential electromagnetic interference due to the monitors in the icu.Telemetry continued to be unsuccessful.The possibility of removing the remaining medication from the pump reservoir was discussed, but the patient's nurses ultimately decided to leave the medication in the pump.No patient symptoms were reported.

Manufacturer Narrative

(b)(4) no longer applies.

Event Description

Additional information was received from a manufacturer representative on 2017-jan-06.It was reported that at the time of the event, the patient was having abdominal issues not related to the device or therapy.The patient was treated with intravenous morphine to help with pain.Per the patient's family, morphine makes the patient hallucinate, and overdose was suspected.The patient's symptoms were later resolved and his chronic pain was under control.The patient was discharged on (b)(6) 2016.The cause of the pump not communicating was thought to be electromagnetic interference.One of the programmers was used to interrogate two other pumps from the representative's trunk stock, and the programmer was able to read those pumps in the room next to the patient's bed.The patient had a refill scheduled for (b)(6) 2017, and the healthcare provider believed that the pump would be able to be interrogated at that time.

Event Description

Additional information was received on 2017-jan-24 from a healthcare provider.It was reported that the inability to communicate with the pump was not able to be resolved.The pump was to be replaced.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.(b)(4).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

Additional information was received from a company representative (rep) via the return paperwork indicated the pump was replaced on (b)(6) 2017 and the catheter was still implanted.The patient was receiving intrathecal morphine 5 mg/ml at 2.49 mg/day (old dose) and the new dose was 0.24 mg/day via the pump.

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

Additional information was received from a healthcare provider (hcp) indicated the patient's height was (b)(6).

Manufacturer Narrative

Analysis of the pump on (b)(4)2017 revealed a foreign material inside the pump.Analysis of the pump on (b)(4)2017 also revealed a high current drain of unknown cause regarding the hybrid.Foreign material was found inside of the top cover of the pump and analysis noted that the foreign material was identified by atr-ir as being consistent with polyvinyl acetate and is nonconductive.Analysis also noted that as received, the pump as not functional; telemetry could not be established and the motor was not running as determined by a listening device.During bench testing it was found that the hybrid had a 20 micro-amp current draw which exceeded specifications (1.7ua ¿ 7.6ua).The hybrid was however also sent for further testing and the hybrid was found to be fully functional and a telemetry failure and high current drain were not confirmed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6228455
• MDR Text Key: 64036506
• Report Number: 3004209178-2017-00343
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2012
• 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): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 84