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

Model Number 7426

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Arthritis (1723); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 12/22/2008

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 3389-40, lot# j0220025v, implanted: (b)(6) 2002, product type: lead.

Event Description

A healthcare provider (hcp) reported that that the patient wanted their lead removed as they believed it was causing them harm.It was stated that the patient was undergoing stimulation for dystonia with a variety ofsymptoms that they feel are directly attributed to the implant, including pain in the left suboccipital area.The healthcare provider (hcp) noted that they did not believe the patient's symptoms were related to the implant.The patient also understood that with ongoing "symptomatic cervical spondylosis" that "every time" and mri scan is required.The patient is adamant that they do not want the electrode as they have concerns of an ongoing indwelling effect, although the hcp has extensively discussed with them that it is almost certainly not the case.It was confirmed that the patient understood the risks of having the explant and the dbs left dbs electrode and microplate fixator were explanted on (b)(6).The patient's indication for implant is dystonia.

Manufacturer Narrative

References the main component of the system and other applicable components are: product id 3389-40, lot# j0220025v, implanted: (b)(6) 2002, explanted: (b)(6) 2008, product type: lead.

Event Description

The patient wanted their dbs information corrected.The patient stated that they did not have a current dbs.Some parts were taken out in 2008.

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; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6218289
• MDR Text Key: 63727056
• Report Number: 3004209178-2017-00034
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2017

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: 05/14/2007
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 01/03/2017
• Supplement Dates Manufacturer Received: Not provided; 01/26/2017
• Supplement Dates FDA Received: 01/31/2017; 09/28/2017
• Date Device Manufactured: 11/16/2005
• 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
• Patient Age: 44 YR