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

Model Number 8637-40

Device Problems No Audible Alarm (1019); Pumping Stopped (1503); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)

Patient Problems Abdominal Pain (1685); Burning Sensation (2146)

Event Date 04/27/2017

Event Type  malfunction  

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) regarding a patient who was receiving dilaudid 10 mg/ml; 1.230 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 pump motor stall was seen at initial interrogation.The logs revealed a stall occured on (b)(6) 2017 at 19:08 with recovery on (b)(6) 2017 at 00:19.A motor stall occurred on (b)(6) 2017 at 14:27 and stopped pump period may exceed tube set on (b)(6) 2017 at 14:27 (no recovery after that).The patient did not recently have magnetic resonance imaging (mri).There were multiple motor stalls and recoveries.The patient did not report hearing an alarm.The critical alarm interval was set to 1 hour.The patient did not have symptoms of withdrawal.The patient¿s diagnosis was ilioinguinal neuralgia.The patient did have a "burning sensation in the stomach" and abdominal pain last week which brought him to the hospital but those symptoms in no way line up with when the pump stalled.The patient had oral pain medication they take when needed but had not taken any recently.It was reviewed that the pump was in a hard stall and to confirm it was stalled, to aspirate from the reservoir.The hcp was expecting 25.6 and got back 36 mls which was about what was calculated if the pump had been stalled since the end of (b)(6) no further complications were reported.

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: 6727233
• MDR Text Key: 80524105
• Report Number: 3004209178-2017-15177
• Device Sequence Number: 1
• Product Code: LKK
• 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,Followup
• Report Date: 07/26/2017

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: 02/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 07/19/2017
• Supplement Dates Manufacturer Received: 07/26/2017; 07/26/2017
• Supplement Dates FDA Received: 07/26/2017; 07/26/2017
• Date Device Manufactured: 09/13/2012
• 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-0497-2013
• Patient Sequence Number: 1
• Patient Age: 88 YR