MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	37601
Medical Device Problem Codes	Break (1069); Intermittent Continuity (1121); High impedance (1291); Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Dysphasia (2195); Complaint, Ill-Defined (2331); Shaking/Tremors (2515)
Date of Event	02/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a healthcare provider via a manufacturing representative about a patient with an implantable neurostimulator (ins) for parkinson's dual movement disorders.It was reported that the patient was experiencing a lack of symptoms control and severe levels of side effects.The patient had dysarthria and turning of the foot due to the surgeon trying to compensate for the lack of symptoms control with programmer.The impedances on the lead were found to be over 40,000ohms.It was reported that the patient is very active which is a contributing factor to the issue.The patient¿s lead was replaced and the open circuit was resolved.No complications or further complications were reported.
Additional Manufacturer Narrative
Other applicable components are: product id: 3389s-40, lot# va0e6h5, product type: lead.
Additional Manufacturer Narrative
Product id: 37601, serial# (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.Product id: 3389s-40, lot# va0e6h5, implanted: (b)(6) 2014, explanted: (b)(6) 2017, product type: lead.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2017, product type: extension.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 event began occurring on (b)(6) 2017.No further complications were reported/anticipated.
Additional Manufacturer Narrative
Information references the main component of the system, other applicable components are: product id 3389s-40, lot# va0e6h5, implanted: (b)(6) 2014, explanted: (b)(6) 2017, product type: lead.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2017, product type: extension.
Event or Problem Description
Additional information was received from a health care provider (hcp) of a clinical study.It was reported that a lead fracture was discovered.The signs/symptoms were reported as increased right hand tremor, surging down the patient's right arm that was episodic as if the device was turn on and off.Worsening left head turning and right mouth pulling with head movement were also noted.It was then stated that the symptoms improved with lower volts, but the tremor remained worsened.The diagnostic methods included a device interrogation on (b)(6) 2017 that resulted in the identification of elevated out of range impedance values.Imaging (x-ray, mri, ct scan, ect) was also performed on (b)(6) 2017 and there was no discontinuity seen.The etiology was noted as related to the device/therapy and not related to the implant procedure; the left stn lead was noted.The actions/interventions taken to resolve the issue included reprogramming the patient on (b)(6) 2017.The left extension was then replaced on (b)(6) 2017, the left lead was replaced on (b)(6) 2017, and the left implantable neurostimulator (ins) was replaced on (b)(6) 2017; the event also resulted in an unscheduled clinic or office visit.The event was considered resolved without sequel ae on (b)(6) 2017.No further complications were reported/anticipated.
Event or Problem Description
Additional information was received from a health care provider (hcp) of a clinical study.It was reported that the clinical diagnosis was updated to sensory and motor changes secondary to lead fracture.No further complications were reported/anticipated.
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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 6482439
• Report Number: 6000153-2017-00019
• Device Sequence Number: 13716586
• Product Code: MHY
• UDI-Device Identifier: 00613994981363
• UDI-Public: 00613994981363
• 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
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/19/2017

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: 11/28/2017
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Device Lot Number: VA0E6H5
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; Not provided; 05/05/2017
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 04/11/2017; 04/27/2017; 05/01/2017; 05/19/2017; 10/03/2017
• 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: Required Intervention
• Patient Age: 52 YR