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

Model Number 37601

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Unexpected Therapeutic Results (1631); Low impedance (2285); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Dyskinesia (2363); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

It was reported that the patient had a loss of therapeutic effect.The reporter wanted assistance in evaluating system integrity and because the implantable neurostimulator (ins) was shutting off.The patient had developed some worsening symptoms in her right leg over the past two weeks.The patient saw the clinician in office on wednesday and was switched to group a.The patient left feeling good, but then felt stimulation was turned off and had worsening symptoms with breakthrough tremor and decline of leg usage.The leg issues resulted in slowness of movement.The patient checked the ins with her programmer and saw stimulation was off.It was not known what happened with therapy when the patient turned back on.The patient was then seen on friday and found that she had switched to group b.The patient was reprogrammed back to group a, but ¿six hours later she felt like it shorted out on her.¿ the device usage seen on friday showed that one day group a ¿had dashes in the middle and said aaa.¿ the patient noted that she did not s witch back and forth often and was mostly in group b.When in group a the patient was more dyskinetic and had some tremor break out.It was also noted that since replacement the patient had not had the same therapy as before.The reporter then saw the patient on the day of the report and took impedances in different positions.While looking up the patient had a low impedance of 60 ohms on electrode combination 2 and 3.The patient also had high impedances over 4,000 ohms while looking down, right, left, and a normal head position on electrode combination 0 and 3.It was also noticed that the battery voltage was 2.96 and dropped to 2.7 during no therapy and then back up to 2.95 again.Two days later it was reported that the patient appeared to be experiencing a short between contacts 2 and 3.The issue was device related and it was unknown how much therapeutic effect was experienced by the patient.The doctor performed x-rays looking for signs of damage.The reporter was able to recreate the low impedance when the patient turned to the right.At the time of the report the plan was to replace the extensions on (b)(6) 2104.

Manufacturer Narrative

Concomitant products: product id 3387s-40, lot # v069269, implanted: (b)(6) 2008, product type lead; product id 3387s-40, lot # v069269, implanted: (b)(6) 2008, product type lead; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2008, product type extension; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2008, product type extension; product id 37642, serial # (b)(4), product type programmer, patient.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

The patient came to the hospital on (b)(6) 2014 when new extensions and an implantable neurostimulator (ins) were implanted.It was discovered that the extension-lead connection had migrated into the patient's neck, so the intracranial leads were disconnected and pulled back to their original connection position behind her left ear.The surgeon saw what appeared to be some kinking of the lead above the boot, which may have been the source of the short.It was later mentioned that the short would occur when the patient turned to the side.When the short occurred, the battery voltage dropped quickly and could have reached 2.6 on an instantaneous reading.There was also suspicion that the 'call your doctor' icon was appearing following short circuit events.The patient had previously reported on 12-jun-2014 that she received 'call your doctor' signs, three and six months ago.The patient could not recall any codes associated with the signs, but the manufacturer representative did come to her house to help at those times.This information was previously considered unrelated, until this additional information was provided.It was also noted that after replacement system impedances were found to be higher than normal, 10,000 ohms, on contacts 3 and 8.The patient returned for programming on (b)(6) 2014 and the high impedances remained.The patient was programmed around that limitation and the reporter had not heard about the efficacy of the therapy following this.

• 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: 3910262
• MDR Text Key: 15322092
• Report Number: 3004209178-2014-12456
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• 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,Followup
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2014
• Date Device Manufactured: 03/13/2013
• 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 Outcome(s): Required Intervention