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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Edema (1820); Erythema (1840); Fever (1858); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Pocket Erosion (2013); Sepsis (2067); Tachycardia (2095); Urinary Tract Infection (2120); Vomiting (2144); Hernia (2240); Complaint, Ill-Defined (2331); Post Operative Wound Infection (2446); Abdominal Distention (2601); Test Result (2695); No Code Available (3191)

Event Date 04/14/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: catheter.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer's representative (rep) regarding a patient receiving 500 mcg/ml lioresal baclofen at a dose of 100 mcg/day via an implantable infusion pump.It was reported that on (b)(6) 2017 the patient became septic and was admitted back to the hospital following implant on (b)(6) 2017.The hcp was not aware of an environmental/external/patient factors that may have led or contributed to the issue.The pump and catheter were explanted, the bowel was repaired and the patient remained in the intensive care unit (icu).It was unknown if the issue was resolved at the time of this event.Both the pump and the catheter were explanted and were not to be returned as they were discarded.The patient's status was "alive- with injury" at the time of this report.The pump eroded through the fascia and caused a strangulated hernia.Part of the bowel was resected and pump/catheter were removed.

Manufacturer Narrative

The pump was returned for analysis.Pump analysis found no anomaly.The catheter was returned for analysis.Catheter analysis found that the pin connector/collet was not fully locked into place.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.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 main component of the device system; the other relevant components include: product id: 8780, serial (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional (hcp) on 2017-aug-02 indicated the patient¿s past medical history prior to the implant of the pump on (b)(6) 2017 included blindness, cerebral palsy (hc code), chronic constipation, convulsive disorder (hc code), dextrocardia, mental retardation, seizures (hc code), and visual field defects.The patient¿s principal diagnosis was spastic quadriparesis.Past surgical history was reported as abdominal exploration surgery, foot surgery (pins in both feet), and replacement of a joint hips.The pump implant operation details regarding the implant on (b)(6) 2017 were reported with the following information.The was an implantation of tunneled intrathecal catheter, with lumbar laminectomy, and connection to implanted abdominal programmable baclofen pump including programming.Procedure performed in the left lateral decubitus position.The patient was given the appropriate weight-based dose of intravenous antibiotics prior to incision and cerebrospinal fluid (csf) was encountered under high flow.The intrathecal catheter was then placed through the tuohy needle into the intrathecal space, under direct visualization, and fluoroscopy confirmed this to be passed to approximately t2.At t2, a significant amount of resistance was encountered.The tuohy needle was then withdrawn.The butterfly stay connector was attached to the intrathecal catheter.A large pocket was then created over the rectus fascia using blunt dissection and bovie electrocautery.The pocket was large enough to accommodate a 40 cc baclofen pump.The sutureless connector was attached to the intrathecal catheter, and then this was attached to a 40 cc programmable baclofen pump that had been pre-loaded with 40 cc of 500 mcg/ml of baclofen.Both wounds were copiously irrigated with normal saline containing bacitracin, and both wounds were closed in layers.There were no complications.The pump was programmed to deliver 100 mcg/day of baclofen.The patient was allowed to successfully emerge from anesthesia, was extubated, and transported to the postanesthesia care unit for postoperative monitoring.The patient¿s current discharge medication list included for the patient to start taking keflex 500 mg capsule (take 1 capsule by mouth 2 times daily) from (b)(6) 2017.At the time of discharge from the pump implant, the patient neuro/physical exam was listed as ¿awake, eyes open spontaneous, does not regard, pupils work, contracted x4, tone improved, abdominal binder in place, pump incision c/d/i (clean/dry/intact).¿ issues to be addressed post discharge were to ¿follow up with the doctor in the clinic within 2 weeks and follow up with physiatrist for pump and oral baclofen titration.¿ the discharged condition after implant was listed as ¿fair.¿ the patient was taking ¿baclofen (lioresal) 10 mg tablet, using 1.5 tablets (15 mg total) by mouth 3 (three) times daily with a 90 tablet quantity and 4 refills.¿ the associated diagnoses were cerebral palsy with spasticity.The patient tolerated the procedure well and was transferred to the floor in stable condition.At that time, the patient was at his baseline tolerating a diet, his pain was well controlled and he was otherwise stable so he was cleared for discharge.The patient was discharged on (b)(6) 2017.It was further reported; the patient was admitted to the hospital on (b)(6) 2017 for sepsis.The patient was brought to the hospital on (b)(6) 2017 for profuse vomiting.In the emergency department (ed) the patient was found tachycardic, febrile, had a presence of cellulitis in the area above the reservoir that was surgically implanted two days ago.Labs ¿revealed presence of elevated lactic acid to 4.0, creatinine 1.95, baseline 0.51, gluc, white blood cell count (wbc) 19.4, and elevated blood urea nitrogen (bun) (32-49).The patient had turbid urinalysis (ua) with pyuria.The patient also had a decreased urine output per report.The patient¿s valium was increased to 10 mg three times a day (tid).The patient¿s abdomen remained dis tended with peri-incisional erythema.It was noted the patient¿s baclofen pump was inserted two days ago ((b)(6) 2017), now returning with fevers and hypotension associated with sepsis.The patient needed source control, fluid resuscitation, and supportive care.The baclofen pump was removed and strangulated bowel found within the pocket which required bowel resection by general surgery (gs).The baclofen pump and intrathecal catheter were to be removed due to the patient presenting with fevers, hypotension associated with sepsis two days post-operative.There was concern for hardware infection and possible intraabdominal involvement.The plan was to operate to remove hardware and explore the abdominal wall with gs.The patient was already on broad spectrum antibiotics and had fluid resuscitation.The explant procedure details on (b)(6) 2017 consisted of the following information.After awake time out patient was given antibiotics and intubated.He was placed in lateral decubitus position with right side up and prepped and draped for the abdominal and the spinal incisions.The previous spinal incision at the lumber level is opened, the suture holding the catheter is removed and the catheter is pulled out of the intrathecal (it) space.Its tip was sent for cultures.Wound closed in layers after irrigation.When the abdominal site was opened, edematous bowel was immediately visible which prompted an urgent intraoperative gs consult.The pump with its connection to the intrathecal catheter was removed and sent for pathology.At this point operation was taken over by the gs team.The doctor would dictate her part of the case separately.The post-operative diagnosis was hardware infection with hernia of the bowels into the abdominal wall.¿ the plan was ¿appreciate surgical intensive care unit (sicu) care, return to nsgy service after acute abdominal needs, ensure no baclofen withdrawal, valium 5 mg tid, follow cultures, frequent q2h turning to allow back wound healing, ok for heparin sc from neurosurgery's perspective.¿ neurological exam showed all extremities were loose, minimal withdrawal to noxious but per rn, when suctioning, they were moving all extremities, and abdominal and lumbar dressing c/d/i, abdomen remained distended but improved on (b)(6) 2017.Inpatient medications were reported as 500 mg ascorbic acid (intravenous, daily), 15 ml chlorhexidine gluconate (mouth/throat, q12h), 5 mg diazepam (iv push, q8h), 1 mg folic acid (iv push, daily), hydromorphone pf, insulin regular human (subcutaneous, q6h), 40 mg prantoprazole (iv push, daily), phenylephrine, 100 mg phenytoin (dilantin iv push or ivpb) (intravenous, q8h), 4.5 g piperacillin-tazobactam (zosyn, iv newborn/pediatric) (intravenous, q6h), 100 mg thiamine (intravenous, daily), 500 mg vancomycin (vancocin iv newborn/pediatric) (intravenous, q6h), with continuous infusion of d5 ½ ns at 100 ml/hr and 10 mg/ml propofol (diprivan) at 10 mcg/kg/min.The neurosurgery consult note from (b)(6) 2017 showed the patient was on valium and dilaudid as needed.The patient remained tachycardic and febrile overnight and thought to be 2/2 sepsis.The healthcare provider (hcp) was awaiting culture results, blood culture ¿no growth to date.¿ the patient¿s white blood cell count (wbc) 6.3 from 19.8.The cxr showed left costophrenic angle opacity, with possible aspiration.The plan was to extubate the patient on (b)(6) 2017 and per the progress notes provided, the plan for the patient was sepsis management per the sicu team, recommended broad spectrum antibiotics, chest x-ray (cxr), trend lactates, make sure back dressing was dry, continue valium, and go to neurosurgery service when out of the icu.The patient was neurologically stable.The patient¿s abdomen remained distended at this time and the patient remained febrile.

• 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: 6497547
• MDR Text Key: 72918888
• Report Number: 3004209178-2017-08398
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2017
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 23 YR