MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM VENTRICUALR & PERITONEAL CATHETERS WITH BACTISEAL; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Model Number	82-3072
Health Effect - Clinical Code	Hearing Loss (1882)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
As reported by the sales rep, two weeks after a shunt procedure involving a bactiseal catheter kit, the patient reported hearing loss.Doctor is wondering if codman has any known antibiotic toxicity reports when using bactiseal.
Additional Manufacturer Narrative
Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.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.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: HAKIM VENTRICUALR & PERITONEAL CATHETERS WITH BACTISEAL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle, CH240 0; SZ CH2400
• MDR Report Key: 7736089
• Report Number: 1226348-2018-10528
• Device Sequence Number: 806081
• Product Code: JXG
• UDI-Device Identifier: 10886704041313
• UDI-Public: (01)10886704041313
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K003322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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
• Operator of Device: Health Professional
• Device Model Number: 82-3072
• Device Catalogue Number: 82-3072
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other