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

Model Number 8637-40

Device Problems Temperature Problem (3022); Excessive Heating (4030)

Patient Problems Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Seroma (2069); Swelling (2091); Burning Sensation (2146); Discomfort (2330); Complaint, Ill-Defined (2331); Fluid Discharge (2686)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient who was receiving clonidine and dilaudid at unknown doses and concentrations via an implantable infusion pump for non-malignant pain.It was reported that the patient stated the pump was radiating heat.The patient reported when you press your hand on where the pump is implanted it is radiating heat and the heat is coming from the pump.The patient also had fluid coming from the incision site.The patient reported the fluid leaks out and the doctor told them this was normal.The patient reported the doctor had removed a lot of fluid from around the pump.The patient reported that the tissue around the incision site is red, swollen, inflamed, tender, and hot to the touch.The patient reported the fluid started to build up shortly after the implant.The patient reported the symptoms started in the past week.No out of box failure was reported.There was no medical/therapy problem related to a small components product reported.It was reported the symptoms were brought on suddenly.No further complications were anticipated/reported.Additional information received from a healthcare provider via a clinical study reported the patient was receiving hydromorphone ( 30.0 mg/ml at 4.494 mg/day) and clonidine (250.0 mcg/ml at 37.45 mcg/day).It was noted the patient was examined on (b)(6) 2017 during a pump refill appointment and a seroma at the pump site was encountered during pump refill appt.The patient was recommended to utilize an abdominal binder.Also, during this examination 55 cc of yellow fluid was aspirated from the pump pocket.The patient was again examined on (b)(6) 2017 and redness and hardness was noted around the pump.During this examination 23 cc of fluid was aspirated from the pump pocket.It was indicated the event was related to the device or therapy and related to the implant procedure.It was noted the event was ongoing.Additional information received from a healthcare provider via a clinical study reported an infection at the pump site.It was noted, on (b)(6) 2017, the patient had increasing pain and redness along the pump reservoir incision over the past couple days.The patient's right lower abdomen was found to be inflamed and hot to the touch.The patient was administered bactrim ds one tablet bid x 10 days.The patient reported on (b)(6) 2017, they felt 100% better and denied any pain with minimal erythema noted.On (b)(6) 2017, the patient reported increased pain and redness over the pump for the last 24 hours.The patient was examined and there was a erythema surrounding the pump incision, no palpable fluid, no drainage, slightly tender with palpation.The patient was again administered bactrim ds 1 tablet bid x 10 days.The event was noted as ongoing.The cause of the infection was not determined.The patient's baseline weight was (b)(6).

Manufacturer Narrative

Corrected as product problem had no been selected.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.

Event Description

Additional information received from a healthcare professional (hcp) via clinical study indicated that the event resolved without sequelae on (b)(6) 2018.On (b)(6) 2018 examination revealed slight redness, area was soft non-tender, and there was no hardness, swelling, edema, or drainage/draining.No further complications were reported/anticipated.

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): 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: 7206359
• MDR Text Key: 97770739
• Report Number: 3004209178-2018-01015
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 07/27/2017
• 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: 68 YR
• Patient Weight: 109