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

Model Number 37602

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)

Patient Problems Tingling (2171); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported a few days following the patient¿s replacement surgery, they noticed a tingling on their chest as well as up and down their right arm.It was noted, the lead was in the left ventral intermediate nucleus (vim).The patient¿s right hand and arm would kind of go into a ¿flailing mode¿ and it would affect their motor coordination.It was described as intermittent shocking symptoms.The old implantable neurostimulator (ins) was at the exact settings but at a lower amplitude.An electrode impedance test was performed and c0 showed high at 2360 ohms.It was noted the intermittent shocking occurred a few times a day and they could reproduce it if the patient pushed on the ins.When the patient pressed on the ins the impedance test was redone and c0 showed 1217 and the tingling sensation faded.It was noted the issue appeared with 0.It was further reported on the day of report in the operating room they tried to re-enact the impedances but it showed normal the entire time.It was noted the doctor went ahead and replaced the ins on the day of report.

Event Description

Additional information reported there was a greater than 50% symptom reduction for the patient.The ins was confirmed to be involved with the event.Impedances were checked pre- and post-operation in july.The cause was not determined and it is unknown if it is device-related.The patient recovered without permanent impairment.

Manufacturer Narrative

Product id 37642, serial# (b)(4); product type programmer, patient product id 3387s-40, lot# v157349, implanted: 2008 (b)(6); product type lead product id 7482a66, serial# (b)(4), implanted: 2008 (b)(6); product type extension (b)(4).

Manufacturer Narrative

Analysis of the neurostimulator, serial #(b)(4), found no anomaly.It was connected to a known good extension and lead and the impedances were measured to be good on every electrode pair.It also functioned properly through other tests.

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.

Manufacturer Narrative

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

• 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: 3922599
• MDR Text Key: 4520604
• Report Number: 3004209178-2014-12719
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2015
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2013
• 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
• Patient Age: 00067 YR