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

Model Number 7426

Device Problems Break (1069); High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Low Battery (2584)

Patient Problems Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that the patient complained to the neurologist of a shocking sensation in her left chest when the implantable neurostimulator (ins) was turned on and programmed.The ins¿s were at the end of their lives and upon replacing them a fracture was noticed in the distal end of the extension near the connector.The impedances were high, greater than 2,000 ohms, on electrodes 0 through 3.The patient had less than 50% therapy relief.The extension was to be replaced at a later date.Confirmation of extension replacement and the patient outcome were not reported, so additional information was requested.If additional information is received, a supplemental report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension.Product id: 3389-40, lot# v006632, implanted: (b)(6) 2006, product type: lead.Product id: 7426, serial# (b)(4), implanted: (b)(6) 2006, product type: implantable neurostimulator.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension.Product id: 3389-40, lot# v006632, implanted: (b)(6) 2006, product type: lead.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported the patient's extension had not been replaced yet.

Event Description

Additional information received reported that an extension revision was scheduled, but not yet completed.

Manufacturer Narrative

Analysis of the extension found (b)(4) found the conductor in the body of the extension was broken and the wire was coiled in the body.The outer insulation of the extension body had a breached depression.The #3 conductor was broken 3.2 cm from the proximal end due to the breached depression.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.

Event Description

Additional information received reported that during an implantable neurostimulator (ins) replacement the healthcare professional opened up the pocked and saw a broken extension.The ins was being replaced due to normal battery depletion.There was no patient injury and the patient had recovered without sequela.

Event Description

Additional information received reported the patient was going in on (b)(6) 2014 for a replacement of their left extension as there was a fracture and that was the reason for the shocking sensation.Additional information received the patient did have the lead extension replacement and the patient's status was unknown.It was further reported the extension was cut/broken near the ins connector head.Intraoperative electrode impedance resulted in no problems found and they were in normal range.The patient was programmed to therapy settings prior to the finding of the open circuit and it was completed by the doctor in recovery and the patient did not have any side effects.The patient had an improvement of symptoms with the new extension and programmed settings.

Event Description

Additional information received from a consumer reported the patient was getting zapped and a wire was broken with their prior implantable neurostimulator (ins).The issue was discovered by the patient's health care provider (hcp) in 2010 and the left ins was turned off.From 2010 to 2014, the patient just had therapy from the right ins due to the left side being turned off.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 4118184
• MDR Text Key: 4924318
• Report Number: 3004209178-2014-17707
• 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,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2006
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2005
• 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