MAUDE Adverse Event Report: MPRI ACTIVA; DEEP BRAIN STIMULATOR FOR OBSESSIVE COMPULSIVE DISORDER

Model Number	3391S-40
Medical Device Problem Codes	Break (1069); High impedance (1291); Peeled/Delaminated (1454); Device Damaged Prior to Receipt by User (1570); Low impedance (2285); Device Operates Differently Than Expected (2913); Impedance Problem (2950); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer via a manufacturer representative regarding a patient with an implantable neurostimulator.It was reported that the lead seemed more stiff than the others implanted that day.When the impedances were checked during implant electrode 3 showed out of range low < 50.The healthcare professional (hcp) then pulled the electrode out of the extension and wiped it off twice.They noticed there was a small wire coming out of the lead by the electrode.They then placed the lead back in the extension and did the test again in that electrode then showed over 10 ,000.The hcp did not want to remove the lead from the extension another time and they felt it would damage the integrity of the lead even more.The issue was resolved at the time of the report.There were no patient symptoms or further complications reported as a result of the event.
Additional Manufacturer Narrative
Fdd (b)(4) no longer applies.
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Common Device Name: DEEP BRAIN STIMULATOR FOR OBSESSIVE COMPULSIVE DISORDER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6630816
• Report Number: 2649622-2017-07505
• Device Sequence Number: 19055700
• Product Code: OLM
• UDI-Device Identifier: 00643169313552
• UDI-Public: 00643169313552
• 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
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/28/2017

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: 12/17/2018
• Device Model Number: 3391S-40
• Device Catalogue Number: 3391S-40
• Device Lot Number: VA14P8R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 06/28/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 06/09/2017; 06/28/2017; 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1