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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Rash (2033); Therapeutic Effects, Unexpected (2099); Ulcer (2274); Complaint, Ill-Defined (2331); Impaired Healing (2378)
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 consumer regarding a patient receiving an unknown dose and concentration of bupivacaine and morphine via an implantable pump for non-malignant pain. It was reported the patient had a new pump implanted in the last year and over the past year, the patient has had a ¿crazy rash¿ and sores and ¿stuff. ¿ no interventions were mentioned. It was indicated the issue began about a year ago. The patient was redirected to their healthcare provider. No further complications were reported or anticipated. Additional information received from a healthcare provider (hcp) via a manufacture representative. It was reported the implanting physician noted that the patient had a rash/skin condition in the abdomen over the pump location. This is the second mdt pump. The patient did not experience any problems with first pump implanted, but has experienced it with the second. There were no troubleshooting or diagnostics performed and the issue was not resolved. The patient's weight was not available. The patient had a rash or allergic reaction over the sight of the pump. Additional information was received from the healthcare provider (hcp). The physician was asked to clarify the report that the patient had experienced a rash and sores since their pump was implanted and indicate if there was a device or therapy issue. The hcp stated they did not know. It was unknown if there was a device or therapy issue which caused or contributed to the reported symptoms. Regarding troubleshooting and diagnostics performed, the patient was seen by an allergist and wound center. The patient was stable at the present time. Regarding actions and interventions taken to resolve the patient¿s symptoms, the hcp stated they were trying to resolve the issue, thus far with no results. The patient¿s medical notes were provided from (b)(6) 2018. The patient returned to the pain management center for continued evaluation and treatment of multiple pain problems. The patient had multiple pain issues including various parts of their body, which included the neck and lower back. The patient also reported neuropathy and reported their liver and splenic arc were enlarged which was causing them to have increased pain. The patient¿s abdomen would get distended. The patient had been on pain medications for the past 8 years. The patient reported the medications being given appeared to be keeping their pain under control. The patient had not been to physical therapy or seen a chiropractor. The patient would come into the office regularly for refills and the patient reported they had been quite active. The patient also reported they had gained a lot of weight and they were on diuretics. The patient had been having a lot of lower back pain radiating into the thighs. The patient also reported they had been having a lot of difficulty with pulmonary hypertension and difficulty with breathing. The patient appeared to be short of breath. The patient was on oxygen 24 hours a day. The patient had undergone a treatment called thermoplasty to help with issues related to bronchial asthma. It had not made a significant difference. The patient had been reasonably stable and was complaining of pain in the knee joint. The patient re ported they had been evaluated by the orthopedic surgeon and would likely required surgery on the knee joint. The patient was upset and reported that she had been experiencing bleeding in the nipple for the last few months. She had recently undergone a mammogram. The patient apparently had multiple cysts in addition to what appeared to be having early stage breast carcinoma. The patient had been advised for surgery to remove them quickly. On (b)(6) 2016 the patient came into the office for a regular refill of their intrathecal pump. The patient reported she had not been doing well. She appeared to be having a lot of pain related to her lupus. The patient had been having difficulty with breathing. The patient had been gaining a lot of weight and was having a lot of fluid retention. The patient was concerned this may have been related to their intrathecal pump. On (b)(6) 2016 the patient came into office and reported significant pain in the left buttock area. The patient had been able to lose 20 pounds. The patient had also been more vigorous with exercise. On (b)(6) 2016 the patient came in for a regular refill of their intrathecal pump. The patient had been experiencing stress due to a social situation. The patient had also been experiencing pain in the left wrist area and pain in the right buttock area. The patient¿s sleep had been very disturbed, but breathing was improved. On (b)(6) 2016 the patient had recently undergone sacroiliac joint injection on the right side. The patient reported she had significant pain relief. The patient was then having a lot of pain in the left side. The patient also reported she had been having a lot of issues related to her carpal tunnel bilaterally. The patient was requesting injections into the carpal tunnel. On (b)(6) 2016 the came into the office for a regular refill of their intrathecal pump. The patient reported that she had been working out and had been losing some weight. The patient also complained of significant pain in both upper tunnels and had been having very severe headaches. This had been continuing for about six months. The patient¿s primary care physician had been giving fioricet. On (b)(6) 2016 the patient came in for a regular refill of their intrathecal pump. The patient reported they had been doing reasonably well. The patient had apparently been diagnosed with diabetes mellitus. The patient reported they started their medication and they were losing weight steadily. The patient reported there were some concerns that she may have a pheochromocytoma. The issue was being investigated but surgery was not indicated. (b)(6) 2017 the patient came into the office for a regular refill of their intrathecal pump. The patient indicated they had been doing reasonably well. The patient indicated they had gained a lot of weight and had been retaining fluid. (b)(6) 2017 the patient came into the office for a regular refill of their intrathecal pump and appeared to be having a lot of issues. The patient indicted that she may have been having some problems passing urine. The patient had also been experiencing vaginal bleeding. The patient also reported it appeared that the intrathecal pump had moved. The patient indicated they were retaining fluid. The patient was exercising for 2 hours a day but appeared to not be losing weight. On (b)(6) 2017 the patient came into the office complaining of significant pain in bilateral arms. The patient was requesting trigger point injections into the carpal tunnel bilaterally. The patient continued to have other medical issues. On (b)(6) 2017 the patient came to the office for her regularly scheduled appointment for her intrathecal pump. The patient indicated that she had been evaluated by a new rheumatologist. The patient indicated there was some concern about her kidney function. The patient also indicated that she had been having a lot of blood in her stools. The patient was referred to a gastroenterologist. The patient reported significant distention in their abdomen. On (b)(6) 2017 the patient came to the office and reported they had recently undergone replacement of their intrathecal pump. The patient also reported they were bitten by a spider. The patient appeared to be having a rash. The patient was concerned that there may be an infection around the area. On (b)(6) 2017 the patient came to the office and reported they appeared to be having some concerns that the wound had not yet healed completely. There appeared to be some bleeding in that area. On (b)(6) 2017 the patient came in to the office for her regularly scheduled appointment for her intrathecal pump. The patient indicated they had been having some concerns regarding the incision on their abdomen. It appeared the incision was gradually healing. The patient also indicated that she had been working with her neurologist for her headaches and migraine. They were apparently given a combination of tramadol and topiramate. On (b)(6) 2017 the patient came in to the office urgently. The patient indicated there appeared to a skin lesion on the pump. The patient had been evaluated by their primary care physician. The primary care doctor had the patient on antibiotics which had not been very adequate for the patient. On (b)(6) 2017 the patient came in to the office for their regular refill of their intrathecal pump. The patient was frustrated because of the skin issues near the intrathecal pump. The patient indicated they had been evaluated by a dermatologist and had been given antibiotics. The antibiotics did not appear to be addressing the issue. The patient also reported feeling tired. On (b)(6) 2018 the patient came to the office and reported they had not been doing very well. The patient indicated they had fallen about a week ago appeared to have had a myocardial infraction. The patient indicated they may have had a possible concussion. The patient was evaluated in the emergency room and had an ekg (electrocardiogram) which indicated there was possible fluid in the lung. The patient also had a computed tomography (ct) scan which may have shown the patient had pneumonia. On (b)(6) 2017 the patient was evaluated by the emergency room doctor and was then sent to her physician for possibly biopsy of the lesion across the anterior abdomen. The patient indicated there was no diagnosis. The patient had since been evaluated by a nurse practitioner, who indicated the patient may have pemphigus. The patient was being treated with antibiotics and steroids. The patient also reported they were likely to be admitted and given a dose of antibiotics and steroids. The patient had been sleeping a lot. On (b)(6) 2018 the patient came in to the office for their regular refill of their intrathecal pump. The patient indicated that they were still very frustrated because there appeared to be no clarification for their situation. The patient continued to have a big skin lesion on the anterior abdomen on the left side. No diagnosis had been made and it was not healing. On (b)(6) 2018 the patient came in to the office for their regular refill of their intrathecal pump. The patient indicated the skin lesion had become a big problem. The lesion had been causing her significant pain. The patient reported the use of the intrathecal pump had not been adequate to control the pain. The patient had seen multiple doctors who had no idea for the cause of the skin lesion. Symptoms included: fatigue; fever; sleeping problems; unintentional weight gain; itchy eyes; and loss of vision; dizziness; nasal congestion; blacking out or fainting; chest pain (unspecified as to activity); heart murmur; irregular or fast, pounding heart beat; leg cramps or pain in legs when walking a short distance; swelling including ankles or legs; shortness of breath or difficulty breathing; wheezing; cough (non-productive); abdominal pain, diarrhea, and nausea; blood in the urine; change in urinating pattern; and frequency urination; limitation of use of joint, muscle pain; back pain; neck pain; joint pain; stiffness in joints; joint swelling; headache; loss of bladder control; loss of bowel control; seizures of unknown type; weakness; trouble sleeping; increased neck size, increased thirst; excessive bleeding after injury or minor surgery; easy bruising; neck masses; rash after contact with a specific substance. Constitution: pain scale; movement (1-10) 10. Blood pressure: right arm. Sitting 213/121 mm hg. Brachial pulse: 108 bpm regular. (b)(6). Musculoskeletal: gait: limp while walking mild. Station normal. Cervical spine: normal to inspection. Tenderness in midline at c5 - mild, tenderness off midline bilaterally in a symmetrical distribution in the trapezius - mild, at c5 - mild. Thoracic spine: normal to inspection. Tenderness in midline at t9 ¿ mild lumbar spine: epidural insertion site has small amount of blood. Slightly tender. Tenderness in midline at l3 ¿ mild; at l4 ¿mild. Tenderness off midline bilaterally in a symmetrical distribution in the paraspinous muscles - mild at l3 ¿ mild. Swelling in the right middle finger. Left elbow and forearm: slight hyperaemia and increased temperature. Tenderness: present posterior elbow - mild. Swelling: present elbow joint- mild. Tenderness present in right tibia - distal leg anterior moderate swelling. Tests and procedures performed [(b)(6) 2018]: pump reprogrammed and refilled with morphine 40 mg per ml and bupivacaine 20 mg per ml. The daily dose of morphine was not changed. The personal therapy manager (ptm) was changed. Next refill was scheduled for (b)(6) 2018. Assessment of current problems: other local infections of skin and subcutaneous tissue; lupus erythematosus; spondylosis without myelopathy or radiculopathy, lumbar region; other cervical disc degeneration, mid-cervical region; other intervertebral disc degeneration, lumbar region; sacroiliitis, not elsewhere classified. The patient was advised to avoid cigarette smoke and contact the office if there were any problems. Continue home remedies. Continue present treatment plan. Continue with current medications. Continue with home exercise program as tolerated. Plan to follow-up on (b)(6) 2018 for office visit pump refill. The doctor was satisfied with the current pain management. The patient indicated that she was having significant neuropathic pain. A small dose of lyrica was introduced. She will start at 50 mg at nighttime and increase it to 75 mg and then 100 mg. She will call with an update in 10 days. Prescriptions for the necessary medications were given. The patient was seen on (b)(6) 2018 for a regular refill of their intrathecal pump. The patient continued to have significant issues with the skin lesion around the area of insertion for their intrathecal pump. The issue had been going on for about one year. The patient reported there may have been some improvement in the situation, but the area appeared to be a lot larger. Review of symptoms: no change exam: no change blood pressure: right arm - sitting 209/110 mm hg. Brachial pulse: 100 bpm regular. Respirations: (b)(6). Tests and procedures performed [(b)(6) 2018]: pump reprogrammed and refilled with morphine 40 mg per ml and bupivacaine 20 mg per ml. The daily dose of morphine was not changed. The personal therapy manager (ptm) was changed. Next refill was scheduled for (b)(6) 2018. Assessment of current problems includes: carpal tunnel syndrome, left upper limb. Location: bilateral the patient was advised to avoid cigarette smoke and contact the office if there were any problems. Continue home remedies. Continue present treatment plan. Continue with current medications. Continue with home exercise program as tolerated. Plan to follow-up on (b)(6) 2018 for office visit pump refill. It was reviewed the physician did not know the cause of the lesion that started one year earlier with replacement of their pump. Prescriptions for the necessary medications were given. The patient¿s medical history includes: systemic lupus erythematosus; possible diagnosis of rheumatoid arthritis and raynaud disease; possible asthma and chronic obstructive pulmonary disease; hypertension; unspecified arthritis and osteoporosis; shingles; epilepsy. Problems with anesthesia: none. Previous surgery: none. Previous non-surgical hospitalizations: none. Immunizations: has never had immunizations of any kind. Diagnostic and screening tests: gastrointestinal: colonoscopy in 2015. Genitourinary: pap smear in 2008. Integumentary: mammography in 2015. Additional information was received from the hcp on (b)(6) 2018. Regarding the rash/sores, the nurse was asked about the spider bite in the medical records their office provided. Specifically, she was asked for the date of bite, location of bite, onset of symptoms of the skin over the pump site, type of spider, causality. The nurse replied that they did not know. The cause of the symptoms had not been determined. The patient¿s primary care doctor, dermatologist, and allergist all did not know the cause of the symptoms. The rash was still there and would get better and would then get worse. It was noted as on-going. The managing doctor initially thought it was a reaction to the pump material, however, he was not sure. The nurse stated that, based on his understanding, the materials in the pump had not changed and the patient did not have a reaction to their previous pump. The doctor planned to move the pump to a different part of the patient¿s body to see if the affected area would heal in order to determine if the issue was related to the makeup of the pump. The doctor was planning to perform this revision within the next two weeks. It was confirmed the issue began around the time of implant in 2017 (though the specific date was not provided). It was confirmed there were no issues with the previous pump.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare provider (hcp) on (b)(6) 2018. It was reported the patient's surgery was cancelled because of severely elevated a1c levels. After the issue is under control by the patient's primary care doctor, her surgery will be rescheduled.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key8033335
MDR Text Key125973670
Report Number3004209178-2018-24568
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169508156
UDI-Public00643169508156
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/02/2018 Patient Sequence Number: 1
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