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

Model Number	3387S-40
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2017
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
A healthcare professional (hcp) via the manufacturer representative (rep) reported that the lead was bent inside the package on date notified.There were no environmental issues that led to the issue and no diagnostics/interventions performed.A new lead was used, resolving the issue.No further complications are anticipated.The patient's indication for implant is unknown.
Additional Manufacturer Narrative
Analysis of the stylet s/n unknown confirmed the allegation.It was found that the stylet wire was severely bent at the proximal end, near the handle.
Event or Problem Description
On (b)(6) 2017 mpxr (b)(4) , imgx2 (hcp, rep): a healthcare professional (hcp) via the manufacturer representative (rep) reported that the lead was bent inside the package on date notified.There were no environmental issues that led to the issue and no diagnostics/in terventions performed.A new lead was used, resolving the issue.No further complications are anticipated.On (b)(6) 2017 an_rp (rep): nni.The patient's indication for implant is unknown.
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: 6399289
• Report Number: 2649622-2017-02468
• Device Sequence Number: 10925173
• Product Code: MHY
• UDI-Device Identifier: 00643169516540
• UDI-Public: 00643169516540
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/24/2017

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: 08/24/2019
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1BDYV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; 04/24/2017
• Initial Report FDA Received Date: 03/13/2017
• Supplement Report FDA Received Date: 03/23/2017; 04/24/2017; 04/24/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1