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

Model Number 37601

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Fall (1848); Seizures (2063); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that the patient¿s programmer was making increases in voltage too quickly and not working appropriately.The patient¿s wife reported that he was having difficulties for a couple of weeks, but thought it was user error.The wife tried it on the day of the report and found that when she made an adjustment it moved to the maximum setting instead of by 0.1.The nurse practitioner (np) was working with the wife and it seemed as though she was using the programmer appropriately.The np stated that the right lead was the issue and it jumped from 1.6 volts to 2.2 volts when trying to increase by 0.1 volt.This jumping had caused the patient to fall several times and he felt a heavy jolt.The wife stated that the ¿stimulation was spiking, and they made sure that it was not user error on their part, and once she was decreasing the setting, his one setting spiked from 0.7 to 2.2 which sent him into a convulsion when this spike occurred and they could not figure out why it was occurring, but it dropped him to the floor about five minutes ago, but it had been going on for a couple of weeks.¿ the wife stated that this only happened when making adjustments with the programmer and she did not think any of the buttons were stuck down.The wife noted ¿it was the setting on the other side that was spiking, the right side remained consistent.¿ upon return of the patient programmer analysis found the antenna jack broken.The top case assembly was scratched and the bottom case assembly was damaged.C300.The patient outcome was not reported or if a new programmer resolved the issue, so additional information was requested.If additional information is received a supplemental report will be sent.

Manufacturer Narrative

Concomitant products: product id 37642, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # va02y9y, implanted: (b)(6) 2012, product type lead; product id 3708660, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 3708660, serial # (b)(4), implanted: (b)(6) 2012, product type extension.(b)(4).

Event Description

Additional information received reported, the patient programmer was jumping from current settings to max settings during adjustment.The right sided buttons on the programmer seemed less responsive.The patient programmer was replaced and the patient had recovered without permanent impairment.The patient was doing well with their new programmer.

• 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: 4166830
• MDR Text Key: 5023375
• Report Number: 3004209178-2014-19538
• 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,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/22/2014

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: 11/28/2013
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2014
• Initial Date FDA Received: 10/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2014
• Date Device Manufactured: 06/08/2012
• 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): Other