MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37602

Device Problems High impedance (1291); Device Operates Differently Than Expected (2913)

Patient Problems Muscular Rigidity (1968); Neurological Deficit/Dysfunction (1982); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

It was reported the patient had chest pain, a loss of effect, and a lack of symptom control since the replacement of their implantable neurostimulators (ins).The patient had been having slurred speech and issues with controlling their tongue.On the day prior to this report, the patient had bit their tongue bad, which had made their speech even worse.The patient¿s jaw was tight and they almost broke a tooth.Every time the patient had their ins replaced, it took them three months to get the ins properly adjusted and for them to receive any benefit.The patient also had an increase in rigidity and dystonia in their neck and extremities with their left being worse than the right.The patient met with their healthcare professional (hcp) a day prior to this report because their pain was so bad they thought they were having a heart attack.The pain was located in the patient¿s chest near the ins and in their armpits.An x-ray was done and the patient was going to follow up with their cardiologist.The patient was evaluated by their cardiologist and cardiac etiology was ruled out.Impedances were checked and one of the contacts was not being used.Impedances of electrode zero were measured to be greater than 40,000 ohms on the left side.The left ins was programmed to 2-, 3+ at 4.7v, 90 usec, and 145 hz.Impedances of electrode three were measured to be greater than 40 ,000 ohms on the right side.The right ins was programmed to 1+, 2- at 4.2v, 90 usec, and 145 hz.Therapy impedances were measured to be within normal limits on both sides.The patient¿s hcp planned on reprogramming the ins to get efficacy.The cause of the event was not determined.A troubleshooting revision had been scheduled for (b)(6) 2015 due to the high impedances.During the revision, the hcp opened the right incision and noticed the bottom two screws on the ins were not tightened.The hcp loosened all four screws, dried off the extension, and retightened everything.The right side bottom connector for the ins and extension still seemed not tight and there was a small gap, but everything was tightened down.Impedances were then tested and all impedances were within normal limits.The same issue occurred when the left side incision was opened.After the revision, all impedances were within normal limits on both sides and no further troubleshooting was done.Refer to manufacturer report #3004209178-2015-09832.

Manufacturer Narrative

Concomitant products: product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v475868, implanted: (b)(6) 2010, product type lead; product id 37602, serial # (b)(4), implanted: (b)(6) 2015, product type implantable neurostimulator; product id 37642, serial # (b)(4), product type programmer, patient; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v443426, implanted: (b)(6) 2010, product type lead.(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 4802318
• MDR Text Key: 15562179
• Report Number: 3004209178-2015-09834
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2015

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: 07/28/2016
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 05/28/2015
• Date Device Manufactured: 02/02/2015
• 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: 00063 YR