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

Model Number 37603

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Spasm(s) (1966); Therapeutic Effects, Unexpected (2099); Tingling (2171); Dysphasia (2195); Therapeutic Response, Decreased (2271); Numbness (2415); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

It was reported by the doctor that the patient may have a system malfunction as the left side of his body developed a tonic contraction that lasted 30 seconds when the right implantable neurostimulator (ins) was turned off.The patient was seen on (b)(6) 2014 by the doctor and manufacturer representative to have the system evaluated.The patient stated that he had minimal efficacy since (b)(6) 2013 and what little efficacy he did noticed had decreased recently.He was having more speech and tremor problems.Since that date the patient had noticed the tonic contraction on the left side of his face and neck at the moment the ins turned off.The contraction was intense for several seconds and he felt numbness in his tongue.The contraction faded away after ten to fifteen minutes.The configuration was changed multiple times and the contraction was less severe.The patient was not told when the ins was turned off in order to rule out the influence.It was discovered that if the settings were slowly decreased he felt increased parasthesias in his thumb and fingertips, but he did not have the face and arm tonic contraction.Impedances were taken in several positions and while palpating.The impedances were consistent throughout and within normal range.It was noted that the placement of the lead was ¿textbook¿ and there were no historical impedance values available.The patient had reprogramming once a month to address the efficacy issues.It was eventually decided that the patient would have his right ins and extension replaced on (b)(6) 2014.The surgery had not yet occurred, so the patient outcome was unavailable.Additional information will be requested after the reported surgical date and if additional information is received, a supplemental report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, lot# va0a6sn, implanted: (b)(6) 2013, product type: lead.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 3389s-40, lot# va0ab21, implanted: (b)(6) 2013, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) (s/n (b)(4) found no significant anomaly.The ins was functionally okay and there were insignificant anomalies.

Manufacturer Narrative

(b)(4).Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.

Event Description

It was later reported the manufacturer representative spoke to the patient on (b)(6) 2014.The patient's implantable neurostimulator (ins) was changed out and the doctor decided that an ins replacement was a good place to start because it was least invasive.It was noted the doctor also had a theory that the ins was potentially malfunctioning and sending out extra stimulation when turned off.The patient recovered well and when the ins was turned on, 90% of the distal tremor was controlled, 100% of the resting tremor was controlled, and 85% of the proximal tremor was controlled.When the ins was turned off, there was still a small contraction, but it was only about 20% as strong as it had been with the previous ins.Two days later the patient was still getting good therapy, but the full force of the contraction when the stimulation was turned off was present again.One of the contractions that occurred after the ins was turned off was so strong some of the fillings came out of the patient's teeth.It was unclear whether this was due to biting down during contraction or due to another impetus.The patient was going to see their heath care provider on (b)(6) 2014 for another appointment.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received.It was reported the previous ins was defective and replacing it resolved the reported issues.No further complications were reported or are anticipated.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; road 31, km. 24, hm 4; ceiba norte industrial park; minneapolis MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 4102298
• MDR Text Key: 4720028
• Report Number: 3004209178-2014-17382
• 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,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/18/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2014
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 09/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 12/18/2014; 10/16/2017
• Supplement Dates FDA Received: 10/07/2014; 12/15/2014; 12/19/2014; 09/15/2017; 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2013
• 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: 60 YR