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

Model Number 37612

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that the patient experienced a shocking or jolting sensation.After an upgrade to a rechargeable implantable neurostimulator (ins), the patient experienced shocking and jolting down their right arm.Impedance testing was performed and all measurements were within normal ranges.It was noted that the patient required fairly high amplitudes to control essential tremor.Amplitude was decreased, which resulted in a ¿less extreme¿ shock.The patient was programmed in bipolar mode in both hemispheres.The ins was implanted in the left pectoral region.The patient reported the shocking sensation was similar to what was felt when stimulation was being switched from off to on.Postural changes did not seem to cause or alleviate the shocking.The patient was admitted to the hospital.Stimulation to the left brain was decreased from 5.4 v to 4.0 v, after which the patient no longer experienced the shocking sensation, but the patient then experienced compromised therapy to their right side.Impedances were checked again and were still within normal ranges.Impedances were as follows: c<(>&<)>0 868, c<(>&<)>1 820, c<(>&<)>2 883, c<(>&<)>3 498, 0 <(>&<)>1 1168, 0<(>&<)>2 1353, 0<(>&<)>3 1097, 1<(>&<)>2 1168, 1<(>&<)>3 1016, 2<(>&<)>3 1022, c<(>&<)>4 846, c<(>&<)>5 698, c <(>&<)>6 692, c<(>&<)>7 736, 4<(>&<)>5 907, 4<(>&<)>6 1068, 4<(>&<)>7 1168, 5<(>&<)>6 768, 5<(>&<)>7 968, 6<(>&<)>7 816.Therapy impedances were also measured and within normal ranges.Exploratory surgery was performed on (b)(6) 2014.Impedances were again tested on the left brain lead and both extensions and all impedances were within normal range.The ins and pocket adaptor were explanted and replaced.Since the replacement, the patient had not experienced any further shocks.The patient recovered fully.

Manufacturer Narrative

Concomitant products: product id 64002, product type adapter.(b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

Concomitant medical products: product id 64002, implanted: (b)(6) 2010, explanted: (b)(6) 2014, product type: adapter.Product id 3550-29, product type: accessory.Analysis of implantable neurostimulator model 37612 sn: (b)(4) found no anomalies.

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 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: 4103211
• MDR Text Key: 4697294
• Report Number: 3004209178-2014-17422
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2014
• 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): Hospitalization; Required Intervention