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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SOLETRA

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MEDTRONIC PUERTO RICO OPERATIONS CO. SOLETRA Back to Search Results
Model Number 7426
Device Problems Replace; Inappropriate Shock
Event Date 01/01/2009
Event Type  Injury  
Manufacturer Narrative

 
Event Description

The device had been working appropriately; the pt had no difficulties turning off the device at night. The pt reported spontaneous turn-off of the device; on one occasion it cause him to slump out of his chair, he hit the back of his head and got briefly dazed. When the pt turned the device back on, he felt an abrupt "jolt" with exaggerated head tremors and hand tremors that settled down gradually over 45 minutes instead of the usual 3 to 5 minutes. Treatment was initiated for possible epilepsy with no change in symptoms, so treatment was discontinued. At physical exam left tenderness over nape of neck, connectors from burrhole to ipg intact, intentional action tremor. Ipg reads -2+1, amp 3. 1 pw 90 rate 185, 45% usage time, multiple activations, impedance 1016, ampl 5. 6, 45% usage time. Battery voltage 3. 75. The pt was admitted to the hosp for observation; for device malfunction and sudden stimulation surges, causing confusion/presyncope and resultant concussion. Two days later, the device was replaced. It was reported he recovered without sequela.

 
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Brand NameSOLETRA
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 PUERTO RICO OPERATIONS CO.
road #31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
charlotte gasperlin
7000 central ave.
minneapolis , MN 55432-3576
7635263952
MDR Report Key1328006
Report Number3004209178-2009-01384
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/28/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date10/28/2009
Device MODEL Number7426
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer02/17/2009
Is The Reporter A Health Professional? Yes
Device Age7 mo
Event Location Other
Date Manufacturer Received01/28/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/28/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/26/2009 Patient Sequence Number: 1
Treatment
IMPLANTED:
IMPLANTED:
EXPLANTED:
EXTENSION: MODEL 7495-51
LEAD: MODEL 3387
EXPLANTED:
PROGRAMMER: MODEL PROGRAMMER
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