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

Model Number 37602

Device Problems High impedance (1291); Low impedance (2285); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Muscle Spasm(s) (1966); Muscular Rigidity (1968); Neurological Deficit/Dysfunction (1982); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Hip Fracture (2349)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37602, serial (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 748251, serial (b)(4), implanted: (b)(6) 2004, product type: extension.Product id: 748251, serial (b)(4), implanted: (b)(6) 2002, product type: extension.Product id: 3387-40 lot# j0225534v, implanted: (b)(6) 2002, product type: lead.Product id: 3387-40 lot# j0123285v, implanted: (b)(6) 2002, product type: lead.The main component of the system.Other relevant device(s) are: product id: 748251, serial/lot (b)(4), ubd: 14-jun-2008, (b)(4); product id: 748251, serial/lot (b)(4), ubd: 01-oct-2006, (b)(4); product id: 3387-40, serial/lot (b)(4), ubd: 05-sep-2006, (b)(4); product id: 3387-40, serial/lot (b)(4), ubd: 19-nov-2005, (b)(4).For other implantable neurostimulator (serial (b)(4)) see regulatory report # 3004209178-2018-10192.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for the treatment of parkinson's disease and movement disorders.It was reported the patient was having daily occurrences of spasms that the patient felt across their whole body but particularly on their left side.While these spasms were occurring, the patient often held his left arm and it felt tight with muscles contracted.The patient twisted their body during the spasm and it was painful for the patient.During spasms, the patients mouth curved to the left, his tongue would hang out, and the left side of his body drooped.The caller reported the patient had three spasms during the course of the call.It was reported the patient had falls since the spasms began in (b)(6) 2018 which could be related to the issue.The patient had a bad fall that involved a hip fracture on (b)(6) 2018 and had surgery on (b)(6) 2018 to replace the hip joint and the caller felt the patient's spasms had gotten worse since this surgery.The patient also reported her deep brain stimulation therapy felt different since the spasms started.Left stn programmed to: opens >40 k on c-3, 0-3, 1-3 and 2-3.Patient programmed to c+1-, 2.5 v, 90 us, 170 hz.The patient was programmed on right stn to: c+1-, 2.4 v, 60 us, 170 hz short 0/2 = 53 ohms 0/3 = 30 ohms, 1/2=34 ohms 1/3 = 36, 2/3 = 38 ohms.On the day of the call high and low impedances were identified.The caller was unsure if the opens and shorts had been seen prior to the day of the call.The patient was last seen to get their system checked in late (b)(6) 2018.The caller did not know if the patient had any programming changes at that time.The patient was told that the spasms were part of the parkinson's disease progression.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturing representative indicating that the cause was not definitively determined.Troubleshooting done to resolve the issue was turning off the device.They do not have knowledge of whether the issues were resolved since the time of the call.A follow-up call was placed on (b)(6)2018 to the physician account for updates but none was given at the time.

• 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: 7489964
• MDR Text Key: 107450122
• Report Number: 3004209178-2018-10193
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761057
• UDI-Public: 00613994761057
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2016
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 05/15/2018
• Supplement Dates FDA Received: 05/15/2018
• Date Device Manufactured: 03/17/2015
• 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: 69 YR
• Patient Weight: 53