MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. MICROSENSOR SKULL BOLT KIT; DEVICE, INTRACRANIAL PRESSURE MONITORING

Model Number	82-6638
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	05/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.Refer to mdr: 1226348-2018-10509 for information regarding the second device reported in this event.
Event or Problem Description
As reported by the ous affiliate, that two icp microsensors did not work, they showed -99 during the implant process.A normal reading was achieved after a 3rd icp sensor with a different batch number was used.There were no reports of delays or patient harm.
Additional Manufacturer Narrative
(b)(4).The sensor was visually inspected.There was no damage to the sensor, catheter material or connector.Functional testing was then performed.The device passed electronic, noise, linearity/hysteresis, and signal drift tests.A review of both component and finished good manufacturing records found no discrepancies.Based on the results of the investigation, the reported issue could not be conformed.The device functioned as intended.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: MICROSENSOR SKULL BOLT 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: 7718320
• Report Number: 1226348-2018-10508
• Device Sequence Number: 19086547
• Product Code: GWM
• UDI-Device Identifier: 20886704042386
• UDI-Public: (01)20886704042386(10)172434
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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: 82-6638
• Device Catalogue Number: 82-6638
• Device Lot Number: 172434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1