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

Model Number 8637-40

Device Problems Temperature Problem (3022); Appropriate Term/Code Not Available (3191)

Patient Problems Burn(s) (1757); Skin Inflammation (2443)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id 8709, serial# (b)(4) implanted: (b)(6) 2003, product type catheter; ubd: (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturing representative (rep) regarding a patient receiving 2,000 mcg/ml of gablofen at 297.39 mcg/day via an implantable pump for intractable spasticity and cerebral palsy.It was reported the patient was in the hospital and had a magnetic resonance imaging (mri) procedure because they arrest[ed] after a nasal surgery.The rep reported they were contacted and asked to interrogate the pump.The patient¿s mother also noticed that the patient had a burn on her back.The rep stated there was a horizontal eight-inch dark line and some blisters going across the crease of the patient¿s back at the incision where the catheter was implanted.The rep reported the patient had the mri at 15:45 and the pump had recovered at 16:12.It was reported the patient¿s symptoms were sudden.Technical services reviewed that the catheter is silicone and the manufacturer would not anticipate any burning in the back.It was reported the event occurred on (b)(6) 2018.No further complications were reported or anticipated.Additional information was received from the manufacturing representative (rep) on (b)(6) 2018.The rep reported that the patient's implantable infusion device and therapy was not thought to have caused or contributed to the patient's hospitalization following a nasal surgery and arrest.It was indicated the patient's mom noticed the horizontal eight-inch dark line and some blisters going across the crease of the patient¿s back following the mri, and there were no other known contributing factors.It was unknown if it had been determined if the mri caused the dark line and blistering at the catheter implant site.The rep was not aware of any further diagnostics or actions taken/planned.As of (b)(6) 2018, the patient was doing fine.

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

The evaluation codes have been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare provider on 2018-jul-30.The hcp reported the mri was done at a different facility.Per the family, the skin darkening occurred after the mri was done.They were unsure if the patient was lying on an object that may have caused this.The family attributed it to the pump/catheter.Regarding further diagnostics performed, it was indicated a pump study would be performed.Regarding further actions planned, it was indicated the hcp was waiting on a mri report of the patient's spine.

• 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: 7476530
• MDR Text Key: 107590022
• Report Number: 3004209178-2018-09742
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 09/09/2014
• 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 Age: 37 YR
• Patient Weight: 69