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

Model Number 37612

Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3387-40, lot# j0217197v, implanted: (b)(6) 2002, product type: lead.Product id: 748240, serial# (b)(4), implanted: (b)(6) 2002, product type: extension.(b)(4).

Event Description

The patient reported that he met with a manufacturer representative (rep) on (b)(6) 2015 for a manual recharge.He had been in over discharge since (b)(6) 2015 and he "had to open his hand" during the call.He also mentioned that he never got many results from his implantable neurostimulator (ins).It was implanted because of a head injury, but he was still waiting for it to provide some relief.He was desperate for relief of the severe tone in his hand and leg.The patient called back on (b)(6) 2015 because he was concerned about the difference between the recharger screen icon showing the full ins battery and the programmer screen icon showing a full battery.His programmer showed 75% and the recharger showed 100%.However, during the call he connected both devices and both showed 100% since the recharger filled up the ins.He was also informed that the two devices could display different increments; the programmer able to show smaller increments.The patient also reported that after the rep restarted the ins after the over-discharge his settings were different than they used to be.The patient's indications for use were dystonia and movement disorders.The patient outcome was not reported, so additional information was requested.If additional information is received a supplemental report will be sent.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the patient reported the patient "gave up on it" because, the device had been ineffective after the "first" six months.They had neurosurgery to get it installed but it only seemed to provide effective relief just enough to experience any level of relief.After six months to the time of report, it was "not even noticeable at all".The manufacturer representative had encouraged and coached the patient on how to keep the device charged.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the company representative reported the nurse could not read the implantable neurostimulator (ins) with the clinician programmer and the patient programmer (pp) could not read it either.There was an alleged overdischarge.They continued recharging and were told to clear the power on reset (por) as soon as the ins was charged to 25%.

• 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: 5031327
• MDR Text Key: 24564847
• Report Number: 3004209178-2015-16732
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Followup
• 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: 09/28/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2015
• Date Device Manufactured: 11/07/2013
• 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 Age: 00042 YR