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

Model Number	3389S-40
Medical Device Problem Code	Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Codes	Stroke/CVA (1770); Infarction, Cerebral (1771); Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Tingling (2171)
Date of Event	01/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a health care provider (hcp) of a clinical study regarding a patient who was implanted with a neurostimulator for essential tremor and movement disorders.It was reported that the patient experienced a stroke that was not related to the device/therapy, but possibly related to the implant procedure.It was also reported that at 2v of stimulation, the patient had an abnormal sensation on the right side of their body that could not be localized to any one part.At 3v of stimulation, the patient could identify paresthesia on their right hand, which was brief.At 4v of stimulation, the patient identified paresthesia on their 1st and 2nd fingers of their right hand, which was also brief.The diagnostics methods included a post-operative mri that showed evidence of a left corona radiata subacute lacunar infarct.Interventions were stated as being administering heparin two days in a row starting on (b)(6) 2017; the event resulted in prolongation of an existing hospitalization.The event was resolved without sequelae on (b)(6) 2017.
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
Additional information was received from a health care provider (hcp) of a clinical study.It was reported that the etiology was updated to not related to the device/therapy, but related to the implant procedure; surgery/anesthesia was noted.
Event or Problem Description
Additional information was received from a health care provider (hcp) of a clinical study.It was reported that the etiology was updated to not related to the device/therapy, but related to the implant procedure; surgery/anesthesia was noted.
Event or Problem Description
Additional information was received from a health care provider (hcp) of a clinical study via a manufacturer representative (rep).It was reported that the patient's weight at baseline was (b)(6).
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: 6293361
• Report Number: 2649622-2017-00060
• Device Sequence Number: 40901
• Product Code: MHY
• UDI-Device Identifier: 00613994981363
• UDI-Public: 00613994981363
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA1BWGN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; 04/05/2017
• Initial Report FDA Received Date: 02/01/2017
• Supplement Report FDA Received Date: 03/10/2017; 03/29/2017; 04/12/2017; 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 54