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

Model Number	3708660
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Itching Sensation (1943); Muscular Rigidity (1968); Discomfort (2330)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary #pli 10, 20: evaluation determined that standard investigation is needed because it was reported that the patient's left side extensions were tethering.The reported information is an allegation that suggests a possible failure of a device, labeling, or packaging to meet specifications.An assessment of the source information indicates a potential relationship between the adverse event(s) reported and the alleged device failure.Assessment determined that there is not an existing formal investigation for the issue identified in this event.However, a new formal investigation is not possible, because there is inadequate information to initiate formal investigation activities; the root cause of why the patient's extensions were tethering is unknown.Concomitant medical products: product id: 37601, serial#: (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 3708660, serial# (b)(4) implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: extension.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: extension.Product id: 37601, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 23-oct-2018, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 23-oct-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received that the left neck is still tight and sore over the extension wire.He does scratch the area.Extension site is very tight.

• 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: 10055907
• Report Number: 2649622-2020-09348
• Device Sequence Number: 2848621
• Product Code: MHY
• UDI-Device Identifier: 00613994749116
• UDI-Public: 00613994749116
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2020

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: 12/05/2019
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1