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

Model Number 37603

Device Problem Low impedance (2285)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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

A manufacturer representative (rep) reported that the patient is showing a low impedance on their left implantable neurostimulator (ins).Impedances for 0 and 1 were shown to be 33 ohms, with all other pairs within acceptable ranges.There were no patient symptoms alleged and follow up is being performed to obtain further information.Indication for implant is dystonia.

Event Description

Additional information was received from a manufacturer representative (rep).It was reported that the cause and the date of when the low impedances began occurring was unknown.It was noted, however, that they began occurring during the post-operative period.It was also unknown if the patient experience any symptoms associated with the issue.The rep stated that the actions/interventions taken to resolve the low impedances included programming around the low impedance pair.

Manufacturer Narrative

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5973153
• MDR Text Key: 55466066
• Report Number: 3007566237-2016-03357
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 10/14/2016
• 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