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

Model Number 7426

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Electromagnetic Compatibility Problem (2927)

Patient Problem Fall (1848)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Analysis of the neurostimulator, serial #(b)(4), found no anomaly.The ins was received with the ¿dose¿ option enabled for 30 minutes.The ¿dose¿ option enabled the stimulation output to be turned on, and then output shut off after the specified amount of time.The returned ins output was monitored while stimulation was on.After 30 minutes, the output would shut off.With the ¿dose¿ option enabled, the returned ins was functioning as programmed.

Event Description

The healthcare provider (hcp) and patient reported via the manufacturer representative (rep) that there was concern about the left implantable neurostimulator (ins) battery's condition.After checking the ins in the hospital with the rep, hcp, and patient all together, it was found that the problem was that the ins continuously turned off after 30 minutes.The patient reportedly continuously complained of this to the hcp two years after implant.However, the hcp did not notice why it was happening and thought it was affected by electromagnetic interference (emi) due to electronics.The patient mentioned there were some side effects after two years as she was falling down continuously on the right side.It was later reported that the issue began one year after implant; it was thus unclear if it began one or two years after implant.There was no troubleshooting done on the left ins as it was not easy to check out the problem due to 30 minute gaps after it turned on.The ins was eventually replaced.The patient's health was good and the condition of her health was better than before.However, she still fell down to the right side, so her condition would be continuously checked.The patient's indications for use were unknown.

• Brand Name: SOLETRA
• 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: 5038464
• MDR Text Key: 24379943
• Report Number: 3004209178-2015-16887
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Report Date: 08/05/2015

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: 10/28/2012
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2011
• 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