MAUDE Adverse Event Report: MPRI DBS¿

Model Number	3708660
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins) for essential tremor and movement disorders.The rep reported that the packaging that the extension was delivered in was cracked and therefore not sterile for surgical use.The rep reported that the damage to the packaging was noticed before it was placed on the sterile field, and a new extension was used in the procedure instead.The rep reported that the issue was resolved.No patient symptoms reported.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received: it was reported that the customer had discarded the extension.The information was confirmed with the physician/account.There were no further complications reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.It was reported the cause of the damage was not known.The outer packaging was slightly bent but didn't seem enough to have damaged the plastic inside.The patient weight was updated.No further complications were reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: DBS¿
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7678688
• Report Number: 2649622-2018-11238
• Device Sequence Number: 805294
• Product Code: MHY
• UDI-Device Identifier: 00643169449152
• UDI-Public: 00643169449152
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 01/11/2022
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/10/2018; 09/12/2018; 08/08/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/22/2018; 09/18/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 85