MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Intermittent Continuity (1121); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 02/18/2015

Event Type  malfunction  

Event Description

It was reported that last wednesday the patient had throbbing and spasms near the implantable neurostimulator (ins) on their left side while they were shoveling snow.The throbbing stopped when the ins was turned off.The ins was turned back on and the manufacturing representative was able to replicate the spasm and pulsing by having the patient do ¿wall push-ups.¿ the spasm was triggered by activity.Starting the day of this report, the patient had felt a shocking or jolting sensation when they turned the ins on.The shocking and jolting was on the left side only.The patient turned the ins off at night.Impedances were measured and they were okay.Therapy impedance was measured to be 884 ohms.The spasms and throbbing did not occur when the ins was off, but they returned after the ins was turned on for a minute.The patient was programmed to c+, 20 at 6.7v.An x-ray was done and it was normal.The patient¿s healthcare professional (hcp) did not know the cause of the event and they were waiting two weeks to see if the issue continues.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 37601, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 3387s-40, lot# va0ccdl, implanted: (b)(6) 2013, product type: lead.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 3387s-40, lot# va05uf5, implanted: (b)(6) 2013, product type: lead.(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4598226
• MDR Text Key: 5697523
• Report Number: 3004209178-2015-04673
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2015
• Date Device Manufactured: 04/08/2013
• 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 Age: 00033 YR