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

Model Number 8637-40

Device Problems Failure to Interrogate (1332); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Overdose (1988); Pain (1994); Vomiting (2144); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Sweating (2444); Ambulation Difficulties (2544); Disc Impingement (2655)

Event Date 05/13/2016

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 8780, serial# (b)(4), implanted: (b)(6) 2013, product type: catheter.

Event Description

Information was received from a consumer regarding a patient receiving intrathecal dilaudid and "another type of anesthetic/numbing drug" (concentrations and doses unknown) via an implanted pump for non-malignant pain.The reporter thought it may be bupivacaine, but was not certain.She did not really know the dose and concentration information, but "thought it was 60% or something".The patient had a "bulging disc and stuff like that going on".The managing healthcare provider (hcp) did not think the catheter was working, but was not sure and was waiting for insurance to do further diagnostics.The patient was on pain pills because she was not getting any relief.The event date was (b)(6) 2016 (about three weeks ago).The situation was currently being addressed by the hcp.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received from a consumer and a healthcare provider.The patient¿s concomitant medications include percocet.The patient needs to use a walker and has a history of severe scoliosis.The patient has the spine of a (b)(6).The patient has recently had sweating and vomiting; it was like withdrawal during the dye study procedure.The patient had hospital izationsxx for ct, mri, emg, and a dye study procedure to rule out a catheter kink.On (b)(6) 2016 ¿o l spine¿ was noted, but no results were indicated.On (b)(6) 2016, a venous ultrasound (usv) of the right low extremity revealed a deep vein thrombosis (dvt).On (b)(6) 2016, ¿m l-spcom¿ and a drug panel were noted, but no results were indicated.On (b)(6) 2016, a drug panel was noted, but no results were indicated.On (b)(6) 2016, ¿scoliosis (2 view)¿ was noted, but no results were indicated.¿o pelvis¿ had no acute findings, ¿o lsp wob¿ indicated hardware was unchanged, a drug administered (d/a) pain block was done and a dye study with no problem detected.According to the patient the dye study was done on (b)(6), but according to the healthcare provider it was done on (b)(6) 2016.The reservoir volumes were accurate.On (b)(6) 2016, a 3d lumbar computed tomography (ct) was done with no abnormality.The cause of the potential catheter issue was not determined as the catheter was functioning and there was no problem with the catheter.The patient was instructed to rest.The patient was referred to an orthopedic doctor to help with her medical issues; the situation is being addressed by a healthcare provider.The patient wanted to have the device taken out, but the pump physician said no to taking the device out.They can lower or shut it off, but not remove.

Manufacturer Narrative

The previously applied device code (b)(4) is no longer applicable.

Event Description

Additional information was received from a consumer.It was reported that the patient has been having issues since the second week in (b)(6) 2016 because the pump malfunctioned.Since the second week in may the patient had been in severe chronic pain from the top of her head all the way down to her feet.The pump was described as having "shut down or something" and the patient wasn't told this officially until (b)(6) 2016.It was the patient understanding that the pump wasn't coming on and the patient believed the pump itself was shut down and she felt she had gone through the worst of the withdrawal.In the second week of (b)(6) 2016, the patient experienced multiple issues from the pump malfunctioning including symptoms that started in this timeframe that were not pre-existing.The patient had not received any relief from her pump and had issues walking, etc.That were outcomes from the pump.The patient did a little yard work, laid down, and then the next morning couldn't move.The patient stated she was paralyzed and felt like a nerve was running up and down her spine and she was in chronic pain and from that day forward she didn't get any relief from her pain pump and had problems walking.Due to the pump malfunctioning the patient had been having issues with her lumbar, joints, and bulging discs, and nerve damage which were described as not having been preexisting conditions.It was reported that none of these issues happened until the pump malfunctioned and shut down on her body.It was noted that the only pre-existing issue the patient had was a fusion surgery done on her back 4 years ago in the l5-s1 area and then she was on pain medication and the hcp convinced the patient to get the pain pump.It was further noted that the patient never had menstrual problems (reported in prior calls; refer to (b)(4)) and some of the other issues since the second week of (b)(6) 2016 repeating that the patient had never been like this.The patient was only getting 1% of dilaudid in her pump.A (b)(6) study had been performed the first week in (b)(6) 2016.The patient's physician wanted to perform an epidural injection (spinal steroid) and sacroiliac (si) injection using a scope or light, however they were denied twice for the injections by insurance to treat the patient's pain.The patient started physical therapy and was told that whatever they did with the fusion and pump surgery they messed her up bad.The patient's managing physician told her she has a sick spine.The patient was scheduled to see their managing physician for another refill and was told to be patient and to work with him.The refill was coming up at the end of this month which was believed to be (b)(6) 2016.The patient was however electing not to go back to their managing physician anymore due to the issues with the pump and how she had been handled for her pain needs since; the patient was planning to get an attorney.The patient did not currently have an hcp for pain management.The patient's primary care provider won't touch the pain management issues because of the pain pump.On (b)(6) 2016, a healthcare provider (hcp) and student doctor couldn't communicate with their clinician programmer.The green light wasn't flashing.The patient was told that the pump had malfunctioned and shut down which was noted as probably having correlated with her issues from the second week of (b)(6) 2016.It was indicated that they didn't know the pump had malfunctioned until (b)(6) 2016.Regarding the clinician programmer green light that didn't come on, the patient felt the pump won't alarm when it would be due for a refill and because she wasn't getting that much medication; the patient didn't think she needed to worry about withdrawal when she elects not to have the pump refilled at the end of the month.When the patient visited their hcp on (b)(6) 2016, she was given zofran to take 4 times a day.The patient still takes zofran at night to go to bed and wakes up every morning with chronic pain and nausea and feels the worst of it for the withdrawals she had gone through.The patient was noted as basically going through withdrawals since the second week of (b)(6) 2016.It was indicated that the zofran makes the patient ill.The patient was noted as also having been told no one wants to surgically touch the patient because of where the catheter was in relation to the spine as it could potentially cause permanent paralysis.The patient was electing not to go back to their last managing physician anymore due to the issues with the pump and how she had been handled for her pain needs since.The patient did not currently have an hcp.The old medication in the pump was noted as having been dilaudid at a dose of "45%" mg/day.The pump currently administered dilaudid with concentration 1.0 mg/ml at a dose rate of 0.2498 mg/day.

Manufacturer Narrative

Removed (b)(4).Added (b)(4) to both pump and catheter.

Event Description

Additional information received from the hcp reported that the pump did not malfunction.A dye test confirmed proper functioning on (b)(6) 2016.Additionally, no notes were available to confirm the clinician programmer being unable to communicate with the pump.There was no clinic visit on (b)(6) 2016.The clinician programmer had always worked.Nothing was noted to suspect the programmer did not work; it works.

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 received from a consumer reported the patient had a delivery failure that resulted in a overdose, pain, and hospitalization on (b)(6) 2016.

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5749400
• MDR Text Key: 48190745
• Report Number: 3004209178-2016-12921
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/07/2017

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: 03/14/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2016
• Initial Date FDA Received: 06/24/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 03/22/2017
• Supplement Dates FDA Received: 07/22/2016; 09/09/2016; 10/07/2016; 04/07/2017; 09/23/2017
• Date Device Manufactured: 09/27/2013
• 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): Hospitalization
• Patient Age: 43 YR