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

Model Number 37612

Device Problem High impedance (1291)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, lot# v061739, implanted: (b)(6) 2007, product type: lead.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2018, product type: extension.Product id: 3389s-40, serial/lot #: (b)(4), ubd: 20-dec-2009, udi#: (b)(4); product id: 7482a51, serial/lot #: (b)(4), ubd: 26-sep-2011, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient's implantable neurostimulator (ins) for the treatment of parkinson¿s dual and movement disorders.It was reported the caller needed to troubleshoot an impedance issue.The caller reported they were not with the patient/hcp to do further troubleshooting.The caller stated the patient was getting 50% relief and was down to 40% relief at the time of the call.He had dystonia but had lead in the stn.The patient was getting additional leads in the gpi the next month.The caller mentioned they were filling out the mri form and the c3 value on the left stn was 2666.The caller stated since back in october the values were >2000.The caller stated the patient had an extension replaced in august and prior to that c0 was the "wonky" one.Since that, c3 had been the higher one.The patient was not programmed on 3 even though that was where he got the mot relief and no side effect.The health care professional (hcp) changed him off 3 for programming.No symptoms or complications were reported or anticipated.

• Brand Name: ACTIVA
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8204044
• MDR Text Key: 131699274
• Report Number: 3004209178-2018-28499
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• Combination Product (y/n): N
• Reporter Country Code: UP
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2018
• Date Device Manufactured: 08/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR