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

Model Number 8637-40

Device Problem Volume Accuracy Problem (1675)

Patient Problems Itching Sensation (1943); Muscle Spasm(s) (1966); Muscular Rigidity (1968); Rash (2033); Therapeutic Response, Decreased (2271)

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

The other relevant components include: product id: 8731sc, serial# (b)(4), implanted: (b)(6) 2012, product type: catheter.

Event Description

Information was received from a healthcare professional via a manufacturer's representative regarding a patient who was receiving 20 00mcg/ml lioresal at 135mcg/day via an implantable infusion pump for traumatic brain injury and spasticity.It was reported that the patient had withdrawal symptoms such as increased spasticity, spasms, and itching.It was stated the patient had a visible rash over their right back and leg which could be contributing to her complaint of itching.The patient had not seen a doctor regarding the rash.The patient had a pump refill on (b)(6) 2017 where the expected volume was 28.8ml but the actual volume in the pump was 27ml.The patient had seen their doctor approximately 3 weeks prior to (b)(6) 2017.The doctor increased the pump by 18% with no change in symptoms.The patient had a catheter dye study done on (b)(6) 2017 in which the catheter was unable to be aspirated.The patient was taking oral baclofen and was being referred to a surgeon for a catheter revision/replacement.The surgery hadn't been scheduled at the time of the report.The issue was not resolved at the time of th report.At the time of the report the patient's status was said to be "alive-no injury." no further complications were anticipated/reported. .

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: 6640343
• MDR Text Key: 77546713
• Report Number: 3004209178-2017-12873
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2017

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: 06/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/14/2017
• Supplement Dates Manufacturer Received: 05/18/2017
• Supplement Dates FDA Received: 10/05/2017
• Date Device Manufactured: 12/14/2011
• 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: 27 YR