MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. ICP SENSOR BASIC KIT; DEVICE, INTRACRANIAL PRESSURE MONITORING

Model Number	82-6631
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been reported that the device will not be returned for evaluation.A lot number has been provided.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
As reported by the affiliate, a microsensor was giving negative readings during implantation, a new microsensor was successfully used to get icp readings.The negative readings were noted, the direct link cable was changed; however, that did not fix the issue, then the microsensor was replaced.There were no reports of delay or patient harm.The device will not be returned.
Additional Manufacturer Narrative
Udi : (b)(4).Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.The manufacturing records were reviewed and no anomalies were found.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 and similar issues.At present, we consider this complaint to be closed.

• Brand Name: ICP SENSOR BASIC KIT
• Common Device Name: DEVICE, INTRACRANIAL PRESSURE MONITORING
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle, CH240 0; SZ CH2400
• MDR Report Key: 7710157
• Report Number: 1226348-2018-10503
• Device Sequence Number: 906787
• Product Code: GWM
• UDI-Device Identifier: 20886704042317
• UDI-Public: (01)20886704042317(10)175415
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K914479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 82-6631
• Device Catalogue Number: 82-6631
• Device Lot Number: 175415
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1