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

Model Number 37601

Device Problem Loss of Data (2903)

Patient Problem Muscular Rigidity (1968)

Event Type  malfunction  

Event Description

It was reported that the patient suffered an electric shock of 220 volts while using an autogenous welder.The patient experienced worsening stiffness, ¿a predominance of right side¿, with increased linguial dyskinesias and residual tremor.The patient¿s symptoms had increased in the three days prior to the patient¿s visit with the physician.While the hcp was attempting to adjust the implantable neurostimulator (ins), the device suddenly turned off, with parameters set to 0 volts, 0 microseconds, and 0 hertz.The device had to be restarted.Prior to the patient being shocked, the device parameters and impedances were as follows: left ins: c+, 0-, 1-, 2.8 v, 90 micros, 130 hz right ins: c+, 10-, 3.0 v, 90micros, 130 hz impedances in ohms, measured at 0.7 v: c/3 3183, c/3 4165, 1/3 4107, 2/3 4586, c/8 2128, c/9 4805, c/11 2406, 8/9 5794, 8/11 4201, 9/10 4886, 9/11 6729 after experiencing the shock, the device parameters were as follows: left ins: c+, 1-, 2-, 3.5 v, 90 miros, 130 hz right ins: c+, 9-, 10-, 3.5 v, 90 micros, 130 hz impedances were out of range on electrode pairs c/2 and c/3.

Manufacturer Narrative

(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: 3946919
• MDR Text Key: 16775419
• Report Number: 3004209178-2014-13279
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2014
• Date Device Manufactured: 02/10/2014
• 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