MAUDE Adverse Event Report: UNK CHPV; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Unspecified Infection (1930); Reaction (2414)

Event Date 06/22/2016

Event Type  Injury  

Manufacturer Narrative

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

In the literature search ¿self-injection of household cleaning detergents into a ventriculoperitoneal shunt reservoir during a suicide attempt: a case report and literature review published acta neurochir doi 10.1007/s00701-016-2888-z, it was reported that a (b)(6) female self-injected chemicals into her programmable valve in a suicide attempt.Per the article: ¿self-injection of household cleaning detergents (more specifically, commercial toilet bowl cleaner) into the reservoir of a ventriculoperitoneal shunt (vps) has never been reported in the neurosurgical literature.A right-handed (b)(6) female with a past medical history significant for bipolar depression (with multiple prior hospital admissions for suicide attempts) and pseudotumor cerebri (status-post vps placement from a right frontal approach) successfully injected ~5 ml of toilet bowl cleaner into her ventricular shunt reservoir during a suicide attempt¿.She was taken emergently to the operating room for placement of a left frontal ventriculostomy.Cerebrospinal fluid (csf) sampled intraoperatively showed numerous gram-positive cocci (later determined to be staphylococcus epidermidis).For this reason, her right-sided shunt system was also removed in its entirety.She was treated with broad-spectrum intravenous and intraventricular antibiotics for her bacterial ventriculitis¿ and she went on to make an excellent neurological recovery.¿ at the time of complaint entry no device specific information, i.E.Catalogue/lot number, is available.

• Brand Name: UNK CHPV
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6041561
• MDR Text Key: 57883329
• Report Number: 1226348-2016-10736
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 41 YR