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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Overdose (1988); Sedation (2368)

Event Date 04/02/2015

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) via a clinical study regarding a patient who was receiving dilaudid (hydromorphone) (0.5 mg/ml at 0.55131 mg/day) and bupivacaine (7.1 mg/ml at 7.8285 mg/day) via an implantable pump for non-malignant pain and post-lumbar laminectomy syndrome.On (b)(6) 2015, the hcp reported that the patient was over-medicated and sedated.The patient had been receiving the same intrathecal (it) dose since (b)(6) 2013, so the dose was unlikely related.The hcp was informed that a pacemaker magnet could be placed over the pump for up to 48 hours to stop the it medication infusion.The logs were reviewed on (b)(6) 2015, revealing that a magnet was in fact placed over the pump on (b)(6) 2015.Therapy was resumed the same date via removal of the magnet.The clinical diagnosis was possible it medication side effects.The patient returned to the clinic on (b)(6) 2015 without any associated symptoms, and the event was considered resolved without sequelae as of that date.The event was unlikely related to the device/therapy, and not related to the implant procedure.The event was possibly related to the drug.There was no change in the drug that caused the event.No further complications were reported or anticipated.

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.The cause of the patient¿s overmedication and sedation was not determined.The hcp suspected the it pump medications.

Manufacturer Narrative

Analysis of the device found a reliability non-conformance of the pump motor with gear train anomalies of corrosion and-or wear and-or lubrication and of a stall due to shaft-bearing.Eval code-conclusion no longer applies.

Event Description

Additional information received from a healthcare provider via a clinical study reported the cause of the death was unknown.The cause of the death was no documented.The site indicated the death was not related to the device.

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: 6525950
• MDR Text Key: 73826477
• Report Number: 3004209178-2017-09172
• 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,study
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/19/2017

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: 07/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: Not provided; 06/21/2017; 06/21/2017
• Supplement Dates FDA Received: 05/02/2017; 07/19/2017; 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2012
• 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 Outcome(s): Required Intervention