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

Model Number 8637-20

Device Problems Disconnection (1171); Unstable (1667); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Cerebrospinal Fluid Leakage (1772); Muscle Spasm(s) (1966); Pain (1994); Burning Sensation (2146); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

Other relevant components include: product id: 8711, serial# (b)(4), implanted: (b)(6) 2003, product type: catheter.

Event Description

Information was received from a healthcare provider via manufacturer representative regarding a patient receiving an unknown drug at an unknown concentration and dosage via intrathecal drug delivery pump for intractable spasticity and spinal cord injury/spinal cord disease.It was reported that there was fluid around the pump.The physician feels it's cerebrospinal fluid (csf) versus a seroma.The fluid was noticed during the first refill after the pump replacement in august.The catheter revision was done on (b)(6) 2017 and had a tear where it connected to the pump.Another catheter was used to repair the old catheter.The catheter related issue was not known until the revision was done.The physician tied a suture around the connector that connected to the pump.That suture had worn through the connecter and was dislodged from the pump.The doctor cut off the old piece.The sutureless connector was put onto the old catheter and connected it back to the pump.It was assumed everything was fine with the patient.

Event Description

Additional information was received.It was reported that they were having burning sensation at the pump site.The consumer asked if baclofen is leaking into the abdomen and could be causing it.Patient stated they have not had any falls or trauma.They realized there was something not right with the pump.The patient said they just realized that it was protruding out a little bit and was having spasms in their abdomen, rib, and back.They were not sure exactly when this started but noticed it was really bad on (b)(6) 2016.Patient stated having pain in the area but thought it was from the pump surgery.The burning sensation had gotten better since they went back in there last week.On (b)(6) 2017 they went back in and the catheter tube was disconnected from the pump.It was eroded.They put a piece back on, connected it to the pump and drained spinal fluid.

Manufacturer Narrative

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

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id 8711 serial# (b)(4) implanted: (b)(6)2003 product type catheter patient code (b)(4) applies to the catheter.Patient codes (b)(4) apply to the pump and the catheter.Device code (b)(4) applies to the pump.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional on 2017-jul-17 reported that the patient had a fall in(b)(6) of 2016 and in (b)(6) of 2016 at a refill, a spinal fluid leak was noted and the patient had significant abdominal pain with spasms and pain at their lumbar incision.It was noted that those events occurred at another facility and the hcp did not have further information on the events from that facility.Subsequently, the patient presented to the current facility and was found to have a sub-optimal baclofen dose.The patient's baclofen dose was gradually increased with some, but not significant improvement in their spasms.The pump was noted to be tilted at a 45 degree angle, which was presumed to have been a result of the fall in (b)(6) of 2016, but was still able to be refilled easily. no further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) regarding a patient receiving intrathecal gablofen (concentration unknown) at a dose of 574 mcg/day.Lot number, expiration and ndc were unknown.The initial start date was (b)(6) 2017.The patient height was 179 cm.Additional medications: oxycodone prn, lorazepam prn, belvig, desonide topical, baclofen oral prn for withdrawal symptoms, tylenol prn, mupirocin topical, percocet scheduled and prn, promethazine, cyancocbalamin, hydrochlorothiazide, potassium chloride, gabapentin, sertraline, methylphenidate, torsemide, methadone, marinol prn.

• 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: 6238766
• MDR Text Key: 64422970
• Report Number: 3004209178-2017-00564
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/28/2017

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: 07/14/2011
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 01/10/2017
• Supplement Dates Manufacturer Received: Not provided; 07/17/2017; 08/01/2017; 08/01/2017
• Supplement Dates FDA Received: 01/24/2017; 07/26/2017; 08/28/2017; 09/28/2017
• Date Device Manufactured: 01/26/2010
• 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): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 103