MAUDE Adverse Event Report: MPRI ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	3387S-40
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a lead.It was reported the distal tip of the lead was slightly bent upon opening from a new package.The lead was replaced with a new lead product, same lot and model.The issue was resolved at the time of the report.No patient symptoms or further complications were reported as a result of this event.
Additional Manufacturer Narrative
Analysis confirmed that the distal end of the lead was bent.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.Analysis observed the distal end of the lead was bent at the #0 electrode sleeve.Results code no longer applies.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Fdc code replaced previous code.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Conclusion code updated from (b)(4).Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected conclusion code (b)(4) because, although the device meets design specification, medtronic made enhancements to the design making this the closest code available with respect to this event.Analysis information -- (b)(6) cst pli# 10.Product id# 3387s-40.Below is unedited, system generated text based on the analysis finding code(s) and test results.Analysis confirmed that the distal end of the lead was bent.{electrical testing of the lead determined that continuity was complete and no electrical shorts were observed between circuits.} electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.Analysis observed the distal end of the lead was bent.{the tip of the lead was bent at the #0 electrode sleeve.} 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: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6630835
• Report Number: 2649622-2017-07506
• Device Sequence Number: 16470138
• Product Code: MHY
• UDI-Device Identifier: 00643169516540
• UDI-Public: 00643169516540
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 08/25/2017

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: 10/20/2019
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1FERT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 07/03/2017; 07/14/2017; 08/25/2017; 08/25/2017; 08/25/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 07/05/2017; 08/02/2017; 08/25/2017; 10/05/2017; 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR