SYNCHROMED II
Report
- Report Number
- 3004209178-2016-21507
- Event Type
- Injury
- Date Received
- October 11, 2016
- Date of Event
- September 8, 2016
- Report Date
- February 20, 2017
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 8782, SERIAL# (B)(4), PRODUCT TYPE: CATHETER. PRODUCT ID: 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: CATHETER. PRODUCT ID: 8782, SERIAL# (B)(4), PRODUCT TYPE: CATHETER. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: CATHETER.
ANALYSIS OF CATHETER N628579002 REVEALED NO SIGNIFICANT ANOMALY. IT WAS NOTED THE CATHETER SC CONNECTOR WAS DAMAGED AT EXPLANT. ANALYSIS OF CATHETER N649655005 REVEALED NO SIGNIFICANT ANOMALY. IT WAS NOTED THERE WAS DRIED DRUG, BLOOD, OR A FOREIGN MATERIAL OCCLUSION IN THE CATHETER BODY. EVAL CODE-CONCLUSION AND EVAL CODE-RESULT NO LONGER APPLY.
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.
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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER VIA A CLINICAL STUDY INDICATED THERE WAS A POSSIBLE ALLERGIC REACTION TO THE CATHETER.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A CLINICAL STUDY REGARDING A PATIENT RECEIVING GABLOFEN (500.0 MCG/ML AT 143.93 MCG/DAY) VIA AN IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THERE WAS A CATHETER KINK. THE PATIENT EXPERIENCED INCREASED SPASMS WHICH WAS ATTRIBUTED TO THE WEATHER. EXAMINATION REVEALED INCREASED RIGIDITY ON (B)(6) 2016. THE DAILY INFUSION RATE WAS INCREASED ON (B)(6) 2016. TIZANIDINE WAS ADMINISTERED ON (B)(6) 2016. ORAL BACLOFEN WAS ADMINISTERED ON (B)(6) 2016. FOLLOWING A PRIVATE YOGA SESSION, THE CPSC YOGA THERAPIST REPORTED DECREASED FLEXION IN HER KNEES, LIMITED RANGE OF MOTION IN HER HIPS AND ANKLES, KNEES 'SEEM CLAMPED TOGETHER', LOWER EXTREMITY MUSCLES TIGHT AND HARD ON (B)(6) 2016. A CATHETER ACCESS PORT (CAP) CONTRAST STUDY ON (B)(6) 2016 GAVE RESULTS OF BEING UNABLE TO ASPIRATE FLUID FROM THE CATHETER, INDICATING A PROBABLE KINK. THE ETIOLOGY OF THE EVENT WAS NOTED AS RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. THE OUTCOME OF THE EVENT WAS NOTED AS ONGOING.
ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A CLINICAL STUDY INDICATED THE CAUSE OF THE CATHETER LEAK AND A ARACHNOIDITIS WAS NOT KNOWN.
ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER VIA A CLINICAL STUDY INDICATED "THE CAUSE OF THE KINK WAS NOT KNOWN".
ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER VIA A CLINICAL STUDY REPORTED THE PATIENT HAD SURGERY ON (B)(6) 2016 AND THE CATHETER WAS SPLICED. THE ISSUE WAS UPDATED AS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2016.
ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER VIA A CLINICAL STUDY INDICATED THE PATIENT EXPERIENCED A HEADACHE WHEN HER CATHETER KINKED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA PRODUCT SURVEILLANCE REGISTRY (PSR) REGARDING A PATIENT RECEIVING INTRATHECAL GABLOFEN 1000.0 MCG/ML AT 150.2 MCG/DAY. THE INDICATIONS FOR USE WERE INTRACTABLE SPASTICITY AND CEREBRAL PALSY. THE PATIENT REPORTED A HEADACHE ON (B)(6) 2016, AND THE PUMP WAS REPROGRAMMED. THE PATIENT PRESENTED TO THE CLINIC FOR A DOSE INCREASE AND ALSO REPORTED INCREASED PAIN, INCREASED STIFFNESS, AND NO RELIEF WITH PTM ACTIVATIONS ON (B)(6) 2016. THE PUMP WAS REPROGRAMMED AGAIN ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT'S NEUROLOGIST SENT HER TO THE EMERGENCY DEPARTMENT FOR IMAGING, AS THE PATIENT WAS UNABLE TO MOVE HER LEGS. AN MRI WITH CONTRAST WAS DONE ON (B)(6) 2016, AND IT REVEALED THE CATHETER WAS LEAKING. THE DEVICE DIAGNOSIS WAS CATHETER LEAKAGE. THE HCP DISCUSSED THE NEURO TEAM ASSUMING CARE OF THE PATIENT, AND SHE RECOMMENDED THEY ORDER A MYELOGRAM. THE MYELOGRAM DONE ON (B)(6) 2016 REVEALED ARACHNOIDITIS AND NO REDUCTION IN FLOW. THE CLINICAL DIAGNOSIS WAS ARACHNOIDITIS AT THE CATHETER TIP. THE HCP CONSIDERED A FEW OPTIONS: REPLACING THE BACLOFEN WITH SALINE TO RULE OUT A REACTION TO BACLOFEN, REPLACING THE CATHETER WITH PREVIOUS MODEL TO RULE OUT ALLERGY TO THE MATERIAL OF THE CATHETER, OR REMOVING THE ENTIRE SYSTEM. THE ENTIRE CATHETER WAS REPLACED ON (B)(6) 2016. A REPEAT MRI WITH AND WITHOUT CONTRAST ON (B)(6) 2016 REVEALED RESOLUTION OF ARACHNOIDITIS. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2016. MEDICATIONS BEING USED AT THE TIME OF THE EVENT INCLUDED COMPOUNDED BACLOFEN. THE EVENT RESULTED IN THE FOLLOWING AN UNSCHEDULED CLINIC OR OFFICE VISIT. THE EVENT WAS RELATED TO THE DEVICE OR THERAPY. THE EVENT WAS NOT RELATED TO THE IMPLANT PROCEDURE. IT WAS INITIALLY REPORTED THAT THE EVENT WAS RELATED TO THE DECREASED DOSE OF THE DRUG (BACLOFEN). IT WAS LATER UPDATED SO THAT THE DRUG RELATEDNESS STATEMENT NO LONGER APPLIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 667973 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention |