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

Model Number 7426

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Shaking/Tremors (2515)

Event Date 01/11/2015

Event Type  malfunction  

Event Description

It was reported the parkinson¿s disease patient experienced a right hand tremor and was reprogrammed on (b)(6) 2014.The patient¿s ¿symptom got controlled¿ following the reprogramming, however the patient¿s ¿right hand was trembling again¿ starting the day prior to report.As of nine days after initial report the patient had been reprogrammed and there was no known programming session scheduled.The patient¿s ¿right hand was trembling¿ and it was ¿unknown¿ whether they were receiving effective therapy.Additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative

(b)(4).

• Brand Name: SOLETRA
• 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: 4464624
• MDR Text Key: 20787827
• Report Number: 3004209178-2015-01412
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2015

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: 10/14/2013
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 01/29/2015
• Date Device Manufactured: 04/19/2012
• 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 Age: 00053 YR