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

Model Number 8637-20

Device Problems Difficult to Interrogate (1331); Inappropriate or Unexpected Reset (2959)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

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 consumer receiving sufentanil [70 mcg/ml] at a rate of 75 mcg/day, clonidine [50 mcg/ml] at a rate of 62.9 mcg/day, baclofen [12 mcg/ml] at a rate of 12.58 mcg/day, and dilaudid [8 mg/ml] at a rate of 12.5 mg/day via intrathecal drug delivery pump for non-malignant pain and failed back surgery syndrome.It was reported that a critical alarm occurred due to a low battery reset via the pump logs.There were no reported symptoms and the logs only go back to yesterday and they do not know when the pump started to reset.There were no further complications reported/anticipated.Additional information was received from a healthcare provider (hcp).It was reported that the patient is currently in the hospital and the hcp states that the pump is alarming and is likely due to the low battery reset (lbr).The alarm is bothersome for the patient and they are managing the symptoms in the hospital at this time so they would like the alarm silenced and pump turned off.They do not have access to the clinician programmer.They were able to interrogate and from there silenced the alarm but had issues with completing telemetry for the update.The update almost completed but then the progress stopped.They turned off the programmer and then turned it back on and states after that he was not able to interrogate the pump.They did not hear the pump alarming while he was in the room.The patient is having upcoming spinal surgery so the pump will be explanted then.On (b)(6) 2017, the patient continues to hear the alarm and was again not able to interrogate the pump.

Manufacturer Narrative

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

Event Description

Additional information received from a consumer indicated the patient had injuries of withdrawal and hospitalization.

Manufacturer Narrative

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

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, serial# unknown, product type: catheter; product id: neu_ unknown_cath, serial# unknown, product type: catheter; udi: asku, ubd: unknown.Analysis of the catheter identified hole in the catheter body caused by a deep abrasion.Analysis results for the pump were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.(b)(4) apply to the pump.Apply to the catheter.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: 6756875
• MDR Text Key: 81505868
• Report Number: 3004209178-2017-15975
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2011
• 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-3043-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention