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

Model Number 37603

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2012

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 37603, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.Product id: 3387s-40, lot# va17evv, implanted: (b)(6) 2016, product type: lead.Product id: 3387s-40, lot# v741339, implanted: (b)(6) 2012, explanted: (b)(6) 2016, product type: lead.Product id: 3387s-40, lot# v741339, implanted: (b)(6) 2012, product type: lead.

Event Description

A manufacturer representative (rep) reported a lead issue.It was stated that a new lead was placed and the implantable neurostimulator (ins) was moved due to displacement.The revision occurred in (b)(6) 2016 and the lead was moved because the patient was getting side effects from stimulation since it was initially implanted in (b)(6) 2012-.The patient's indication for implant is dystonia, intractable spasticity, other spasticity and movement disorders.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received.It was reported that interrogation was performed.It was reported that an impedance issue was noticed after implantation.It was noted that lead was not used in programming.It was unknown what the cause of the issue was.It was also noted that the issues were not resolved.

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 Description

Additional information was received from the healthcare professional.It was reported that the cause of the impedance issues was determined; however, no cause was reported.No troubleshooting was reported.

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.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6272450
• MDR Text Key: 65581047
• Report Number: 3007566237-2017-00238
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/23/2017

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
• Device Operator: Health Professional
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/30/2016
• Initial Date FDA Received: 01/24/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 02/13/2017
• Supplement Dates FDA Received: 02/01/2017; 02/23/2017; 09/29/2017
• 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: 13 YR