MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM IN LINE PROGRAMMABLE VALVE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3164

Device Problem Programming Issue (3014)

Patient Problems Headache (1880); Nausea (1970); Pain (1994); Loss of Vision (2139); Discomfort (2330); Sleep Dysfunction (2517)

Event Date 06/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).It has been communicated that the device is not available for evaluation.Without the device it is not possible for codman to conduct a proper investigation.Since a lot number has been provided a review of the manufacturing records will be reviewed.We anticipate that the evaluation will reveal that the device conformed to specifications prior to release.If anything otherwise is found then a follow up report will be filed.If at some point the device does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

Event Description

Per phone calls from patient: patient had a valve implanted in (b)(6) 2015, with valve draining to her heart, that was causing her pain and discomfort.This valve replaced a previously implanted non-codman valve.Patient was concerned with catheter placement and believed that catheter should not be draining to the heart as it could cause complications.The patient stated that since the first week of implant, the valve was "self-adjusting." the patient has experienced consistent headaches.The tubing that goes over her head is so stiff that she can¿t move her head in a certain direction.She is losing her vision (has papilledema), nausea, loss of balance, increased pulse rate and cannot sleep on the side where the shunt was placed (the left).The device implanted was reported as an 826164.The patient was scheduled to have the valve adjusted on (b)(6) 2017.Patient was inquiring whether there was a recall on the device.

Manufacturer Narrative

(b)(4).Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released to stock.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.At present, we consider this complaint to be closed.

Event Description

Additional information received: patient originally had a strata valve implanted.This was implanted at (b)(6).At some point after this, she was involved in a car accident, which resulted in the valve becoming cracked.An 82-3164 chpv was implanted at (b)(6) to replace the strata valve.A pleural catheter was also replaced with a bactiseal catheter.She said the rest of the previously implanted configuration was unchanged.The patient said that the valve is positioned above her left eye, more toward the top of her head.According to the patient, the valve initially drained to her stomach.However, due to scar tissue in the stomach, there was an issue with absorbing the csf.The drain was then directed to the chest, but she again had difficulty with absorbing the fluid, which was collecting in her lungs.Finally, the catheter was configured to drain into her heart.The patient said the valve was changing settings.According to the patient, the radiologist said the valve was set at 70 mmhg and that the neurosurgeon said it was set at 40-60 mmhg.It was unclear whether the setting was confirmed via the programmer or through x-rays.Effects on the patient were reported as increased heart rate, slit ventricles, and passing out.Ms (b)(6) said the issues also resulted in the need for gastric bypass; however, the direct relationship was unclear.Patient reported that multiple spinal taps have been required.

• Brand Name: HAKIM IN LINE PROGRAMMABLE VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6669995
• MDR Text Key: 78479913
• Report Number: 1226348-2017-10448
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 82-3164
• Device Lot Number: CPGB8D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 06/27/2017
• Supplement Dates Manufacturer Received: 06/30/2017
• Supplement Dates FDA Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2013
• 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): Required Intervention