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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Difficult to Advance (2920); Positioning Problem (3009)

Patient Problems Cerebrospinal Fluid Leakage (1772); Pain (1994); Pneumothorax (2012); Twitching (2172); Complaint, Ill-Defined (2331); Numbness (2415); Spinal Cord Injury (2432); Ambulation Difficulties (2544); Alteration In Body Temperature (2682)

Event Date 06/28/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial #: (b)(4), implanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 21-mar-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information as received from a consumer regarding a patient receiving baclofen, 2000mcg/ml at 110mcg/day via an implantable pump.The other medication the patient was taking was oral baclofen 20mg every 6 hours if the critical alarm went off and oral gabapentin.The indication for use was intractable spasticity.The patient¿s medical history included cerebral palsy and surgeries prior to the pump to help the patient walk, mild scoliosis, excessive lordosis and ¿past bone work¿.On 17-jan-2019 it was reported that the implant surgery caused a partial spinal cord injury.Per the patient prior to surgery, a ct scan was done and based off the scan, the physician predicated no issue.The patient met with a np (nurse practitioner) pre-op and had asked they monitor the patient¿s legs prior to the surgery because the patient anticipated issues because the curvature of the patient¿s spine wasn¿t normal due to the patient having mild scoliosis and excessive lordosis.The patient further stated that the physician told her that to monitor her legs he would need a separate authorization which was not obtained.The patient felt that if their legs were monitored, the issue wouldn¿t have occurred.During the implant procedure the patient¿s right lower lung collapsed during the pump implant surgery from the patient being placed on one side for so long as the surgery took 4 hours ¿instead of the normal 1-3 hours¿.The patient stated that during the catheter insertion the physician was aiming for t-8 but the physician got up to t-10 and the catheter kinked so the catheter and spinal needle was removed.The physician re-did it and got the catheter up to t-10, advanced the catheter slightly and the catheter went up and ¿turned on itself¿.The physician noticed twitching in "1 or both of them lower extremities', and the physician told her it was l side.The patient further stated that the physician did a neurological assessment with the patient not fully awake and stated that the patient was at her ¿baseline¿, another assessment was done intra-op and later the physician stated that told him that she could feel during surgery.When the patient woke up she was numb from waist down.After the surgery the patient had a csf (cerebral spinal fluid) leak from the catheter needle being moved.The csf leak was addressed by the healthcare provider but no action was taken and the patient was told it wasn't bad enough to go in to fix.The patient stated that she suffered but within 4.5 months the leak healed on its own and went away.The patient stated issues continue, she has good/bad days and still has some neural function below level of injury.Some days the patient has little slight feeling, bad days are decreased sensation where she can't feel much.The patient stated that if someone pushes hard enough up against legs she can feel pressure.The patient can still feel sensation of pain in legs because in 2017 (prior to pump) the patient had major surgery to help her walk.The patient could walk prior to surgery but now the patient could only stand to pivot.The patient was taught to walk during pt (physical therapy) but walking wasn't good for the patient¿s hips as it can make them tighter.The patient stated that she can't walk after implant surgery and was wondering if she is going to need more leg surgeries to be ambulatory.The patient also stated that after implant surgery she gets these sensations in her legs, like it feels cold in some spots and then warm in some spots.Prior to the pump the patient had tingling because of past "bone work" she has had and already had some numbness because of nerve damage and takes gabapentin for that but what the patient was talking about was new post pump implant.The patient was trying to figure out the numbness that she has which she thinks was from catheter hitting the spinal cord.The patient¿s healthcare provider did an mri and didn¿t see anything that would point to an inflammatory mass.The patient reported that the last time the pump was filled was when it was put in on (b)(6) 2018.The patient also stated that she noticed around 5-6 months of having the pump, that because the medication was old and the patient wasn¿t sure how long the medication would last over 3 months because of body heat, the medication was not working as well.The patient noticed this because her hips and hip flexors were quite spastic, they were probably the tightest they had ever been.The patent requested physician listings.No further complications were reported or anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

On 2019-july-31, additional information was received from the patient.The patient reported that at the end of last year (2018), they discovered the tip access port of the pump was pointing down instead of the naval.The patient had a computed tomography (ct) scan in (b)(6) 2019 and it showed the original placement of the catheter was t10 and the pump maybe turned.There were no symptoms reported.The patient was looking for other hcps in their area.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was reported that the catheter was facing the belly button and that the tip was pointing "more so down." they had been having pain down the length of the catheter since a couple of days ago, relative to (b)(6) 2019.The patient mentioned that they felt as though they had a high temperature, but there were no thermometers in her assisted living facility.The patient felt like they could have better control of their hip region.There were no further complications reported at this time.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8266575
• MDR Text Key: 133710374
• Report Number: 3004209178-2019-01393
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2019
• Date Device Manufactured: 06/08/2018
• 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): Disability
• Patient Age: 27 YR