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

Model Number 7426

Device Problems Battery Problem (2885); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Event Description

Additional information received reported the patient checked the implantable neurostimulator (ins) with the patient programmer a day prior to this report and the ins was showing 2.59v.A week prior to this report the ins showed 2.6 v.The patient had met with their healthcare professional and a manufacturing representative who told them that when the power gets to 2.6v, the ins was nearing the end of battery life.One of the patient¿s ins was showing 2.59v and the other ins was fine.The patient stated ¿much worse than the other and one lasted 3 years and the other 1.5 years.¿.

Event Description

Additional information received reported the implantable neurostimulator (ins) was changed out due to normal battery depletion.A rechargeable ins was implanted.

Event Description

It was reported that the patient checked the implantable neurostimulator (ins) battery a few days prior to the report and saw 2.6 volts.The day prior to the report the patient saw 2.59 volts.However, the patient was not getting an elective replacement indicator (eri) on the programmer even though it was expected at 2.6 volts.Follow-up from the healthcare provider (hcp) reported that it was unknown if there was 50% or greater symptom reduction.The ins was involved in the event and the only troubleshooting performed was following its voltage.The cause of the event was not determined and thus it was unknown if it was device related.The patient outcome was unknown.Refer to manufacturing report #3004209178-2014-19551 as the patient had two ins¿s and it was not specified which was the issue.

Manufacturer Narrative

Concomitant products: product id 7426, serial # (b)(4), implanted: (b)(6) 2010, product type implantable neurostimulator; product id 3387-40, lot # l54557, implanted: (b)(6) 1998, product type lead; product id 7495-51, serial # (b)(4), implanted: (b)(6) 1998, product type extension; product id 7495-51, serial # (b)(4), implanted: (b)(6) 1998, product type extension; product id 3387-40, lot # l54934, implanted: (b)(6) 1998, product type lead.(b)(4).

• Brand Name: SOLETRA
• 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 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: 4167029
• MDR Text Key: 4984907
• Report Number: 3004209178-2014-19553
• 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: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2012
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2014
• Date Device Manufactured: 01/19/2011
• 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