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

Model Number 8637-40

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Wound Dehiscence (1154); Abrasion (1689); Purulent Discharge (1812); Edema (1820); Erythema (1840); Unspecified Infection (1930); Itching Sensation (1943); Pain (1994); Rash (2033); Staphylococcus Aureus (2058); Skin Irritation (2076); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Discomfort (2330); Fluid Discharge (2686)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 1999, product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 18-jan-2001, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient receiving clonidine and morphine at unknown concentrations and doses via an implantable infusion pump.The indication for use was non-malignant pain.It was reported that the shortly (a week or two) after a pump replacement surgery the patient got (b)(6) and had to have the device removed.It was noted that the pump never worked and medication was "spewing through her body" and not going into her spine.The caller stated that she was given intravenous antibiotics and a partial explant was performed.It was noted that they had to leave "part of the probe and tubing" in the patient due to scar tissue.No further complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp) indicated the patient¿s pump was removed due to infection.It was noted a month after the pump was implanted, the patient complained of redness/irritation around the area, she was asked to come back on (b)(6) 2016 and was put on antibiotics.The patient was admitted to the hospital on (b)(6) 2016 and was discharged on (b)(6) 2016.The admitting diagnosis was wound dehiscence, infected pain, and drug pump.The patient¿s history of present illness was reported, and it was noted in (b)(6) 2016 the pump needed to be changed and the pump was replaced on (b)(6) 2016 due to normal end of life.The patient did well initially, however, was seen in the office a couple of times with some irritation around the incision, but it did not appear to be infected.However, on (b)(6) 2016, the patient did have some purulent drainage and the office was contacted due to the patient having redness, warmth, burning, some degree of pain and drainage from the incision.She came to the clinic and a few sutures were placed where the wound was opening.The wound was cultured on (b)(6) 2016 and came back as (b)(6) and was susceptible to bactrim.She was started on bactrim last week in the outpatient setting (week prior to (b)(6) 2016) and had continued to take the antibiotics.It was noted from the infectious disease consult on (b)(6) 2019, though, the (b)(6) was sensitive to bactrim, the symptomology did not entirely abate on bactrim and the patient was admitted in order to have likely removal of the pain pump.It was reported from a symptomatic standpoint, almost all the patient¿s complaints were related to the pain pump region.She had no systemic symptoms of infection such as fevers, shaking, chills, rigors, nausea or vomiting, sweats or new urinary complaints.The patient did have some slight improvement initially when placed on bactrim but that was the symptomatology returned fairly impressively at the pain pump pocket and incisional line.She remained on bactrim at the time of her admission to the hospital.The only other primary complaint was significant itching that had been full body since the time of her surgery and had not found relief with any particular anti-itch methodologies.The patient had tenderness only at the area surrounding the pain pump.At the pain pump incision, there was a some what crusty appearance with overlying edema that extended beyond the immediate incisional line.There were also areas of dehiscence at the incision line with somewhat thickened purulent appearing material evident at the opening.The patient was tender to palpation in this region.The remainder of the skin was also notable for marked excoriations prominent on the extremities, the flanks, and event on the patient¿s face and ears.She was asked to come back to the clinic and presented to the office on (b)(6) 2016 and was made a direct admit to the hospital at that time.It was further reported since her surgery she has had a rash and intense itching over her body, especially over her extremities and had pressure and pain below and behind the pain pump.Physical examination showed no redness with the rash, but the rash had been scratched to the point it bleeds and was in various stages of healing.The area around the incision was warm, erythematous, and a small amount of pale-yellow drainage.She was started on intravenous vancomycin upon admission.The diagnosis was wound dehiscence/wound infection of the right lower quadrant.The patient was taken to the operating room (or) and the procedure was performed and tolerated without difficulty.It was reported there was concern with the amount of medication she had been receiving via the pain pump.However, per the operative note, there was a question as whether or not the catheter was actually in the correct place and that she was really getting that much medication.Post-operative day one the patient was taking oral fluids and voiding and feeling much better.Her pain was significantly improved and was tolerable with the pain medications she was on.Post-operative day two, her incisions were looking good and the abdominal incision, especially that had been the site of infection looked as if it were improving.Infectious disease was also consulted regarding this patient for recommendations of antibiotic therapy.The patient was discharged in stable condition and given prescriptions for clonidine patch to change every week, fentanyl patch 25 mcg, and bactrim ds to be taken for two weeks orally.She was to continue her methadone as well as the rest of her home medications.She was instructed to following up with the clinic in one week.The patient¿s allergies included aspirin, nonsteroidal anti-inflammatory agent, and statins.The patient¿s past medical and surgical history included gerd, anxiety, chronic back pain, chronic constipation, depression and seasonal allergies with spasmodic rhinorrhea, laminectomy, hysterectomy, carpel tunnel release of small bowel resection.No further complications have been reported as a result of this event.

• 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: 8699812
• MDR Text Key: 148021022
• Report Number: 3004209178-2019-11615
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

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: 03/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: 06/24/2019
• Supplement Dates FDA Received: 06/27/2019
• Date Device Manufactured: 10/05/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR