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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2017

Event Type  malfunction  

Event Description

Information was received from a healthcare professional (hcp) regarding a patient who was receiving hydromorphone 5 mg/ml; 1.7666 mg/day, clonidine 400 mcg/ml; 141.33 mcg/day and bupivacaine 25 mg/ml; 8.833 mg/day via an implantable pump.Indication for use was non-malignant pain.The date of the event was (b)(6) 2017.It was reported a motor stall was seen at initial interrogation.The patient recently had magnetic resonance imaging (mri).A motor stall recovery had not occurred.It had not been less than 2 hours since the patient exited the mri field.There was no volume discrepancy when the hcp withdrew the medicine from the reservoir.No symptoms were reported.No further complications were reported.

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).The pump was re-interrogated and a motor stall recovery occurred.The logs indicate the motorstall occurred on (b)(4) 2017 at 1310 and the pump restarted on (b)(4) 2017 at 0951.The motor stall has been resolved.The patient¿s weight at the time of the event was (b)(6) pounds.Medical history includes chronic intractable pain secondary to hereditary angioedema and subsequent multiple compartment syndromes and complex regional pain syndrome (crps).

• 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: 6918848
• MDR Text Key: 89467305
• Report Number: 3004209178-2017-20757
• 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: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2014
• 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: 10/12/2017
• Date Device Manufactured: 04/01/2013
• 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-0591-2009
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 59